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Therapy Name Fluorouracil + Leucovorin + Oxaliplatin
Synonyms FOLFOX
Therapy Description

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Drug Name Trade Name Synonyms Drug Classes Drug Description
Fluorouracil Adrucil 5-FU|5-Fluorouracil Chemotherapy - Antimetabolite 14 Adrucil (fluorouracil) is an antimetabolite chemotherapeutic agent that interferes with DNA and RNA synthesis, thereby preventing cancer cell growth (PMID: 28520376). Adrucil (fluorouracil) is FDA-approved for use in patients with adenocarcinoma of the colon, rectum, breast, stomach, and pancreas (FDA.gov).
Leucovorin Wellcovorin Calcium folinate|Calcium citrovorum factor|folinic acid Chemotherapy - Antimetabolite 14 Wellcovorin (leucovorin) is a metabolite of folate that enhances the efficacy of fluoruracil (PMID: 32490554).
Oxaliplatin Eloxatin Diaminocyclohexane Oxalatoplatinum Chemotherapy - Platinum 7 Eloxatin (oxaliplatin) is comprised of a platinum complex, which causes DNA-platinum cross-links, inhibition of DNA replication and transcription, and cell toxicity, and is FDA approved for colorectal cancer (FDA.gov).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ATM W1058* ATM S1993fs gastroesophageal adenocarcinoma predicted - sensitive Fluorouracil + Leucovorin + Oxaliplatin Case Reports/Case Series Actionable In a retrospective analysis, treatment with the combination of Adrucil (fluorouracil), Wellcovorin (leucovorin), and Eloxatin (oxaliplatin) resulted in a partial response and a progression-free survival of 7.2 months in a patient with gastroesophageal adenocarcinoma harboring ATM W1058* and S1993fs (PMID: 37129948). 37129948

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT03281369 Phase Ib/II Atezolizumab + Cobimetinib Atezolizumab + Cisplatin + Fluorouracil + Tiragolumab Atezolizumab + Cisplatin + Fluorouracil Atezolizumab + Cobimetinib + Fluorouracil + Leucovorin + Oxaliplatin Atezolizumab + Fluorouracil + Leucovorin + Oxaliplatin Atezolizumab + Linagliptin Atezolizumab + PEGPH20 Atezolizumab + BKT140 Paclitaxel + Ramucirumab Cisplatin + Fluorouracil Fluorouracil + Leucovorin + Oxaliplatin Atezolizumab + Tiragolumab A Study of Multiple Immunotherapy-Based Treatment Combinations in Patients With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (G/GEJ) or Esophageal Cancer (Morpheus-Gastric and Esophageal Cancer) Completed USA | ISR | GBR | ESP | AUS 2
NCT05476796 Phase II Fluorouracil + Leucovorin + Oxaliplatin Nivolumab + Oxaliplatin + Trifluridine-tipiracil hydrochloride Oxaliplatin + Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer (LOGICAN) Recruiting FRA 0
NCT03844750 Phase II Fluorouracil + Leucovorin + Oxaliplatin Pembrolizumab Pembrolizumab After Chemotherapy in Treating Patients With Colorectal Cancer That Has Spread to the Liver and Who Are Undergoing Liver Surgery Terminated USA 0
NCT06625320 Phase III Fluorouracil + Leucovorin + Liposomal irinotecan Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Gemcitabine + Nab-paclitaxel Daraxonrasib Phase 3 Study of RMC-6236 in Patients with Previously Treated Metastatic Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) (RASolute 302) Active, not recruiting USA | ITA | FRA | ESP | DEU 2
NCT03611556 Phase Ib/II Gemcitabine + Nab-paclitaxel + Oleclumab Durvalumab + Gemcitabine + Nab-paclitaxel + Oleclumab Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oleclumab + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Oleclumab + Oxaliplatin MEDI9447(Oleclumab) Pancreatic Chemotherapy Combination Study Completed USA | NOR | ESP | AUS 0
NCT04793958 Phase III Adagrasib + Cetuximab Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10) Active, not recruiting USA | ROU | POL | NLD | ITA | IRL | GRC | GBR | FRA | FIN | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG 12
NCT07318389 Phase I Tucatinib Fluorouracil + Irinotecan + Leucovorin Sotorasib Cetuximab Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Oxaliplatin Adagrasib Encorafenib Trastuzumab deruxtecan Bevacizumab Panitumumab ASCEND-CRC: Profiling and Targeting Dynamic Tumor Resistance in Patients With Metastatic Colorectal Cancer Not yet recruiting USA 0
NCT05713838 Phase II Durvalumab + Fluorouracil + Leucovorin + Oxaliplatin Docetaxel + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Durvalumab Organ Preservation With Durvalumab-based Immunotherapy in Combination With Chemoradiation as Definitive Therapy for Early Stage Esophageal Adenocarcinoma With Indication for Radical Surgery Recruiting DEU 0
NCT05870800 Phase II Atezolizumab + Capecitabine + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin Phase II Open-label Trial of Neoadjuvant Immunochemotherapy for Resectable Non-metastatic Colon cancER: NICER (NICER) Recruiting USA 0
NCT03777813 Phase II Fluorouracil + Leucovorin + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Oxaliplatin Association of Radiochemotherapy and Immunotherapy for the Treatment of Unresectable Oesophageal caNcer (ARION) Completed FRA 0
NCT04421820 Phase Ib/II BOLD-100 + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours Recruiting USA | IRL | CAN 1
NCT04210115 Phase III Cisplatin + Fluorouracil + Pembrolizumab Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Cisplatin + Fluorouracil Study of Pembrolizumab (MK-3475) Versus Placebo in Participants With Esophageal Carcinoma Who Are Receiving Chemotherapy and Radiation Therapy (MK-3475-975/KEYNOTE-975) Active, not recruiting USA | TUR | ROU | ITA | HUN | GBR | FRA | EST | DNK | DEU | CZE | CAN | BRA | BEL | ARG 12
NCT06490536 Phase III Fluorouracil + Leucovorin + Oxaliplatin Ipilimumab + Nivolumab Irinotecan + Temozolomide Fluorouracil + Leucovorin Capecitabine Fluorouracil + Irinotecan + Leucovorin Fluorouracil Capecitabine + Oxaliplatin The Sagittarius Trial Recruiting ITA | ESP | DEU 0
NCT02563002 Phase III Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin Cetuximab + Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Pembrolizumab Study of Pembrolizumab (MK-3475) vs Standard Therapy in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Carcinoma (MK-3475-177/KEYNOTE-177) Completed 0
NCT05564403 Phase II Fluorouracil + Leucovorin + Oxaliplatin Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin Study of Chemotherapy, With or Without Binimetinib in Advanced Biliary Tract Cancers in 2nd Line Setting (A ComboMATCH Treatment Trial) Active, not recruiting USA 0
NCT06940388 Phase II Capecitabine Fluorouracil + Leucovorin + Oxaliplatin + Tislelizumab Fluorouracil + Leucovorin + Oxaliplatin Total Neoadjuvant Treatment With or Without Tislelizumab for Locally Advanced Rectal Cancer. (TOTAL) Recruiting ISR | DEU 0
NCT05253651 Phase III Cetuximab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer (MOUNTAINEER-03) Recruiting USA | SVK | POL | NOR | NLD | ITA | IRL | GRC | GBR | FRA | ESP | DEU | CHE | CAN | BRA | BEL | AUT | AUS | ARG 6
NCT04145193 Phase II Durvalumab + Fluorouracil + Leucovorin + Oleclumab + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Oxaliplatin Durvalumab + Fluorouracil + Leucovorin + Monalizumab + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Novel Oncology Therapies in Combination With Adjuvant Chemo in High-risk MSS-CRC Withdrawn 0
NCT05504252 Phase II Fluorouracil + Leucovorin + Oxaliplatin Nivolumab METIMMOX-2: Metastatic pMMR/MSS Colorectal Cancer - Shaping Anti-Tumor Immunity by Oxaliplatin (METIMMOX-2) Active, not recruiting NOR 0
NCT03647969 Phase II Docetaxel + Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Ipilimumab + Leucovorin + Nivolumab + Oxaliplatin Modified FOLFOX Plus/Minus Nivolumab and Ipilimumab vs. FLOT Plus Nivolumab in Patients With Previously Untreated Advanced or Metastatic Gastric Cancer Completed DEU 0
NCT01792934 Capecitabine + Oxaliplatin Bevacizumab + Capecitabine + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Chemotherapy and Maximal Tumor Debulking of Multi-organ Colorectal Cancer Metastases (ORCHESTRA) Active, not recruiting NLD | GBR 0
NCT05052801 Phase III Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression (FORTITUDE-101) Active, not recruiting USA | TUR | SWE | ROU | POL | NOR | LVA | LTU | ITA | ISR | IRL | HUN | GRC | FRA | EST | ESP | DNK | CZE | CAN | BRA | BGR | BEL | AUS | ARG 13
NCT03504397 Phase III Fluorouracil + Leucovorin + Oxaliplatin + Zolbetuximab Fluorouracil + Leucovorin + Oxaliplatin A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer. (Spotlight) Active, not recruiting USA | POL | ITA | ISR | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUS 8
NCT02934464 Phase III Paclitaxel + Ramucirumab Fluorouracil + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin Assessment of Ramucirumab Plus Paclitaxel as Switch MANteInance Versus Continuation of First-line Chemotherapy in Patients With Advanced HER-2 Negative Gastric or Gastroesophageal Junction Cancers (ARMANI) Unknown status ITA 0
NCT07265674 Phase III Fluorouracil + Irinotecan + Leucovorin JPH203 Fluorouracil + Leucovorin + Oxaliplatin A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract Cancer (Beacon-BTC) Recruiting USA 0
NCT03329248 Phase Ib/II Fluorouracil + Leucovorin + Oxaliplatin Avelumab + Bevacizumab + ETBX-011 + GI-4000 + Nogapendekin alfa inbakicept Capecitabine + Cyclophosphamide + Nab-paclitaxel QUILT-3.060: Combination Immunotherapy With High-affinity Natural Killer (haNK) in Subjects With Pancreatic Cancer Who Have Progressed on or After Standard-of-care Therapy. Terminated USA 0
NCT06997497 Phase III Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin Cetuximab + Fluorouracil + Leucovorin + MK-1084 + Oxaliplatin A Clinical Study of MK-1084 With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012) Recruiting USA | ROU | POL | NLD | ISR | GBR | FRA | FIN | ESP | DEU | BRA | AUS | ARG 8
NCT05855200 Phase III Dostarlimab-gxly Capecitabine + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (AZUR-2) Recruiting USA | TUR | SWE | POL | NOR | NLD | ITA | GRC | GBR | FRA | FIN | EST | ESP | DEU | CZE | CAN | BRA | BEL | AUS | ARG 8
NCT02912559 Phase III Atezolizumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin Combination Chemotherapy With or Without Atezolizumab in Treating Patients With Stage III Colon Cancer and Deficient DNA Mismatch Repair Active, not recruiting USA | DEU 1
NCT03530267 Phase II Fluorouracil + Leucovorin + Oxaliplatin Aflibercept + Fluorouracil + Leucovorin Aflibercept and 5-FU vs. FOLFOX as 1st Line Treatment for Elderly or Frail Elderly Patients With Met. Colorectal Cancer (ELDERLY) Completed DEU 0
NCT06333314 Phase II Dostarlimab-gxly Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Doxorubicin Gemcitabine Gemcitabine + Nab-paclitaxel Doxorubicin + Trabectedin Fluorouracil + Leucovorin + Oxaliplatin Cisplatin + Etoposide Cisplatin + Gemcitabine Cisplatin + Doxorubicin + Etoposide Capecitabine + Oxaliplatin Doxorubicin + Ifosfamide Carboplatin + Etoposide Carboplatin + Paclitaxel Docetaxel + Fluorouracil + Leucovorin + Oxaliplatin Mitotane Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal/Non-endometrial) With Tumor dMMR/MSI (Pan-MSI-ACSE) Recruiting FRA 0
NCT05564377 Phase II Selumetinib Binimetinib + Fulvestrant Binimetinib + Palbociclib Nilotinib + Paclitaxel Binimetinib + Fluorouracil + Leucovorin + Oxaliplatin Panitumumab + Sotorasib Binimetinib Fulvestrant Olaparib Olaparib + Selumetinib Alpelisib + Olaparib Neratinib Neratinib + Palbociclib Fluorouracil + Leucovorin + Oxaliplatin Ipatasertib + Paclitaxel Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial Recruiting USA 1
NCT06529718 Phase II Fluorouracil + Leucovorin + Oxaliplatin Ivonescimab Testing Ivonescimab Versus FOLFOX in Advanced Biliary Tract Cancer Patients (SEVILLA) Recruiting GBR | FRA 0
NCT05062317 Phase II Capecitabine Leucovorin Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Risk-Stratified Adjuvant Therapy: ctDNA-Directed Post-Hepatectomy Chemotherapy for Patients With Resectable Colorectal Liver Metastases Recruiting USA 0
NCT05062889 Phase II Fluorouracil + Irinotecan + Leucovorin + Oxaliplatin Capecitabine + Oxaliplatin Trifluridine-tipiracil hydrochloride Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib Exploiting Circulating Tumour DNA to Intensify the Postoperative Treatment Resected Colon Cancer Patients (ERASE-CRC) Suspended ITA 0
NCT02923921 Phase III Fluorouracil + Leucovorin + Oxaliplatin + Pegilodecakin Fluorouracil + Leucovorin + Oxaliplatin Study of AM0010 With FOLFOX Compared to FOLFOX Alone Second-line Tx in Pts With Metastatic Pancreatic Cancer Completed USA | POL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 2
NCT03694522 Phase II Bemarituzumab + Fluorouracil + Leucovorin + Oxaliplatin Fluorouracil + Leucovorin + Oxaliplatin A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer (FIGHT) Completed USA | TUR | ROU | POL | ITA | HUN | GBR | FRA | ESP | DEU | BEL | AUS 6
NCT06044311 Phase II Carboplatin + Paclitaxel Vactosertib Fluorouracil + Leucovorin + Oxaliplatin Oral TGF-beta Receptor I Inhibitor Vactosertib in SOC Chemoradiotherapy for Esophageal Adenocarcinoma Recruiting USA 0
NCT04919226 Phase III Fluorouracil + Leucovorin + Oxaliplatin 177Lu-edotreotide Everolimus Capecitabine + Temozolomide Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) - COMPOSE (COMPOSE) Active, not recruiting USA | NLD | ITA | GBR | FRA | ESP | DEU | AUS 2
NCT04008030 Phase III Nivolumab Fluorouracil + Irinotecan + Leucovorin Cetuximab Fluorouracil + Leucovorin + Oxaliplatin Bevacizumab Ipilimumab + Nivolumab A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) (CheckMate 8HW) Active, not recruiting USA | TUR | ROU | NOR | NLD | ITA | IRL | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG 4


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