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| Therapy Name | Fluorouracil + Irinotecan + Leucovorin |
| Synonyms | FOLFIRI |
| Therapy Description | |
| 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). |
| Irinotecan | Camptosar | CPT-11 | TOPO1 inhibitor 11 | Camptosar (irinotecan) inhibits Topoisomerase-I activity, resulting in inhibition of DNA replication, and potentially leading to cell death and is indicated as a component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic or recurrent colorectal carcinoma (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). |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT05480306 | Phase II | Bevacizumab + Fluorouracil + Leucovorin + Oxaliplatin DKN-01 + Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin | Phase 2 Study of DKN-01 in Colorectal Cancer (DeFianCe) | Completed | USA | DEU | 1 |
| NCT06747845 | Phase II | Fluorouracil + Irinotecan + Leucovorin Ipilimumab + Niraparib | Maintenance Niraparib Plus Ipilimumab in Patients with Metastatic Pancreatic Adenocarcinoma Whose Disease Has Not Progressed on Platinum-Based Chemotherapy (ParpVax2) | Recruiting | USA | 0 |
| NCT04348045 | Phase II | Durvalumab + Selumetinib Fluorouracil + Irinotecan + Leucovorin Olaparib | Maintenance With Olaparib or Selumetinib + Durvaluma for m-PDAC Guided by BRCAness and KRAS Status. (MAZEPPA) | Active, not recruiting | FRA | 0 |
| NCT03665441 | Phase III | Eryaspase + Gemcitabine + Nab-paclitaxel Eryaspase + Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel | Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 2nd-Line Treatment in PAC (Trybeca-1) | Completed | USA | GBR | FRA | 0 |
| NCT01260415 | Phase II | Panitumumab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Fluorouracil + Irinotecan + Leucovorin | A Study of Perioperative Chemotherapy Plus Panitumumab in Patients With Colorectal Cancer Liver Metastases | Completed | CAN | 0 |
| NCT03803553 | Phase III | Binimetinib + Cetuximab + Encorafenib Nivolumab Pertuzumab + Trastuzumab Fluorouracil + Irinotecan + Leucovorin | Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer | Recruiting | USA | 0 |
| NCT01803282 | Phase I | Andecaliximab Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Carboplatin + Pemetrexed Disodium Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Carboplatin + Paclitaxel Paclitaxel Bevacizumab | Safety and Tolerability Study in Solid Tumors | Completed | USA | 0 |
| NCT06252649 | Phase III | Bevacizumab + Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin + Panitumumab + Sotorasib | Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naive Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301) | Recruiting | USA | TUR | SWE | ROU | POL | NLD | ITA | HUN | GRC | GBR | FRA | EST | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BGR | BEL | AUT | AUS | ARG | 9 |
| NCT02046538 | Phase II | Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Aflibercept | Phase II Study of Zaltrap and Chemotherapy for Advanced Resectable Colorectal Cancer | Withdrawn | USA | 0 |
| NCT02753127 | Phase III | Fluorouracil + Irinotecan + Leucovorin Napabucasin | A Study of Napabucasin (BBI-608) in Combination With FOLFIRI in Adult Patients With Previously Treated Metastatic Colorectal Cancer (CanStem303C) | Completed | USA | NLD | ITA | ISR | FRA | ESP | DEU | CZE | CAN | BEL | AUS | 5 |
| NCT01472016 | Phase I | Docetaxel ABT-700 Cetuximab Erlotinib Fluorouracil + Irinotecan + Leucovorin | Study of ABT-700 in Subjects With Advanced Solid Tumors | Completed | 0 | |
| 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 |
| NCT02305758 | Phase II | Fluorouracil + Irinotecan + Leucovorin Bevacizumab Veliparib | Study Comparing Veliparib Plus FOLFIRI Versus Placebo Plus FOLFIRI With or Without Bevacizumab in Previously Untreated Metastatic Colorectal Cancer | Completed | 0 | |
| NCT03336216 | Phase II | Cabiralizumab + Gemcitabine + Nab-paclitaxel + Nivolumab Cabiralizumab + Nivolumab Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Cabiralizumab + Fluorouracil + Irinotecan + Leucovorin + Nivolumab | A Study of Cabiralizumab Given With Nivolumab With and Without Chemotherapy in Patients With Advanced Pancreatic Cancer | Completed | USA | ITA | GBR | ESP | DNK | DEU | CHE | CAN | 3 |
| 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 |
| NCT07337447 | Phase II | Fluorouracil + Irinotecan + Leucovorin AB154 + Fluorouracil + Irinotecan + Leucovorin + Zimberelimab | Trial of FOLFIRI + Zimberelimab + Domvanalimab vs FOLFIRI With a Hybrid Synthetic Control Arm in Second Line Treatment of Neuroendocrine Carcinoma of Gastro-enteropancreatic or Unknown Origin (REWENEC 01) (REWENEC 01) | Not yet recruiting | FRA | 0 |
| NCT01274624 | Phase I | Fluorouracil + Irinotecan + Leucovorin Bevacizumab + Pelareorep | Study of REOLYSIN; in Combination With FOLFIRI and Bevacizumab in FOLFIRI Naive Patients With KRAS Mutant Metastatic Colorectal Cancer | Completed | USA | 0 |
| NCT01488552 | Phase Ib/II | Oxaliplatin Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Metformin | Gemcitabine+Nab-paclitaxel and FOLFIRINOX and Molecular Profiling for Patients With Advanced Pancreatic Cancer | Completed | USA | 0 |
| NCT04554836 | Phase II | Cetuximab + Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin | MoLiMoR - A Study With FOLFIRI-based First-line Therapy With or Without Intermittent Cetuximab | Completed | DEU | 0 |
| NCT01652482 | Phase II | Cetuximab Duligotuzumab Fluorouracil + Irinotecan + Leucovorin | A Study of MEHD7945A + FOLFIRI Versus Cetuximab + FOLFIRI in Second Line in Patients With KRAS Wild-Type Metastatic Colorectal Cancer | Completed | USA | ROU | NZL | ITA | GBR | FRA | ESP | DEU | BEL | 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 |
| NCT03806309 | Phase II | OSE 2101 Nivolumab + OSE 2101 Fluorouracil + Irinotecan + Leucovorin | OSE2101+FOLFIRI, or FOLFIRI Maintenance After FOLFIRINOX-based Induction Therapy in Advanced or Metastatic PDAC (TEDOPAM) | Active, not recruiting | FRA | 0 |
| NCT02213289 | Phase Ib/II | Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Docetaxel + Fluorouracil Trastuzumab Fluorouracil + Irinotecan + Leucovorin Rilotumumab | PANGEA-IMBBP: Personalized Antibodies for Gastro-Esophageal Adenocarcinoma - A 1st Pilot Metastatic Trial of Biologics Beyond Progression | Completed | USA | 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 | |
| NCT04390399 | Phase II | Fluorouracil + Irinotecan + Leucovorin Gemcitabine + Nab-paclitaxel Aldoxorubicin + Cyclophosphamide + Gemcitabine + Nab-paclitaxel + Nogapendekin alfa inbakicept + PD-L1.t-haNK cells Aldoxorubicin + Cyclophosphamide + Gemcitabine + Nab-paclitaxel + Nogapendekin alfa inbakicept | Combination Immunotherapy Plus Standard-of-Care Chemotherapy Versus Standard-of-Care Chemotherapy for the Treatment of Locally Advanced or Metastatic Pancreatic Cancer | Active, not recruiting | USA | 0 |
| NCT01653470 | Phase I | Carboplatin Fluorouracil + Irinotecan + Leucovorin BMS-906024 Paclitaxel | Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid Tumors | Completed | USA | CAN | BEL | 0 |
| NCT05419479 | Phase Ib/II | Fluorouracil + Irinotecan + Leucovorin AB154 + Sotigalimab + Zimberelimab | Switch Maintenance in Pancreatic | Suspended | USA | 0 |
| NCT04205968 | Phase II | Fluorouracil + Irinotecan + Leucovorin Paclitaxel + Ramucirumab | Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers | Recruiting | USA | 0 |
| NCT02024607 | Phase Ib/II | Capecitabine + Oxaliplatin Bevacizumab + Napabucasin Napabucasin + Regorafenib Fluorouracil + Leucovorin + Oxaliplatin + Pembrolizumab Napabucasin Fluorouracil + Irinotecan + Leucovorin | A Study of BBI608 in Combination With Standard Chemotherapies in Adult Patients With Advanced Gastrointestinal Cancer | Completed | USA | CAN | 0 |
| NCT04825288 | Phase Ib/II | Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin + XB2001 | XB2001 in Combination With ONIVYDE + 5-FU/LV (+Folinic Acid) in Advanced Pancreatic Cancer (1-BETTER) | Active, not recruiting | USA | 0 |
| NCT01937715 | Phase II | Bevacizumab Gedatolisib Fluorouracil + Irinotecan + Leucovorin | A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer | Terminated | USA | ESP | CAN | 0 |
| NCT02482441 | Phase I | Rosmantuzumab Fluorouracil + Irinotecan + Leucovorin | A Phase 1a/b Dose Escalation Study of the Safety, Pharmacokinetics, and Pharmacodynamics of OMP-131R10 | Completed | USA | 0 |
| NCT01814501 | Phase II | Fluorouracil + Irinotecan + Leucovorin Panitumumab | Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With Bevacizumab | Completed | USA | 0 |
| NCT02508077 | Phase II | Fluorouracil + Irinotecan + Leucovorin Panitumumab | FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer | Terminated | USA | 0 |
| 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 |
| 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 |
| NCT01312857 | Phase II | Panitumumab Fluorouracil + Irinotecan + Leucovorin Floxuridine | Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type RAS Who Have Resected Hepatic Metastases From Colorectal Cancer | Completed | USA | 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 |
| NCT01298570 | Phase II | Fluorouracil + Irinotecan + Leucovorin Regorafenib | Regorafenib+FOLFIRI Versus Placebo+FOLFIRI as 2nd Line Tx in Metastatic Colorectal Cancer | Completed | USA | IRL | 0 |
| NCT02605044 | Phase III | Masitinib Fluorouracil + Irinotecan + Leucovorin | Study to Compare the Efficacy and Safety of Masitinib in Combination With FOLFIRI to Placebo in Combination With FOLFIRI in Second Line Treatment of Patients With Metastatic Colorectal Cancer | Terminated | GBR | FRA | 1 |
| NCT02890355 | Phase II | Fluorouracil + Irinotecan + Leucovorin Fluorouracil + Irinotecan + Leucovorin + Veliparib | FOLFIRI or Modified FOLFIRI and Veliparib as Second Line Therapy in Treating Patients With Metastatic Pancreatic Cancer | Active, not recruiting | USA | 0 |