irinotecan / Generic mfg. - LARVOL DELTA

Lurbinectedin plus irinotecan in pretreated gastroenteropancreatic neuroendocrine neoplasms: results of a phase II expansion cohort. (PubMed, ESMO Open) - P1/2 | "The combination of lurbinectedin plus irinotecan with primary granulocyte colony-stimulating factor prophylaxis showed antitumor activity in GEP-NECs but limited activity in GEP-NETs. This combination had a predictable and manageable safety profile, with myelosuppression, gastrointestinal disorders, and fatigue as main toxicities. The lurbinectedin plus irinotecan combination deserves to be further explored in GEP-NECs after failure of platinum therapy."

Journal • P2 data • Endocrine Cancer • Fatigue • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Gastrointestinal Neuroendocrine Tumor • Hematological Disorders • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor

Leptomeningeal metastasis from colon cancer: a case report and review of literature. (PubMed, Front Oncol) - "She had received treatment with FOLFOX/FOLFIRI ± bevacizumab...In this review, we summarize 29 cases of LM-CRC, aiming to characterize the pathology, symptoms, diagnosis, and survival data of LM-CRC in order to enhance clinicians' awareness of this rare disease. The incidence of LM-CRC is low and the prognosis is extremely poor; active anti-tumor therapy may prolong patient survival."

Journal • Brain Cancer • Colon Cancer • Colorectal Cancer • Constipation • Gastroenterology • Gastrointestinal Disorder • Oncology • Pain • Rare Diseases • Solid Tumor • KRAS

Distal cholangiocarcinoma mimicking pancreatic ductal adenocarcinoma successfully converted to resection following PD-1/CTLA-4 bispecific immunotherapy (cadonilimab) combined with nab-paclitaxel-based chemotherapy: a case report providing preliminary real-world insight. (PubMed, Front Oncol) - "While PDAC is commonly treated with gemcitabine plus nab-paclitaxel (AG regimen) or FOLFIRINOX as neoadjuvant or conversion therapy, first-line treatment for cholangiocarcinoma (CCA) typically consists of gemcitabine plus cisplatin (GC regimen), with or without immunotherapy...This report offers a preliminary real-world therapeutic insight from a single case, suggesting that dual immune checkpoint blockade combined with chemotherapy may enable conversion surgery in selected patients with CCA. Further studies are warranted to elucidate the underlying immunological mechanisms."

Journal • Real-world evidence • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

RAGNAR: Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab (clinicaltrials.gov) - P2 | N=1 | Terminated | Sponsor: Grupo Espanol de Tumores Neuroendocrinos | N=87 ➔ 1 | Trial completion date: Dec 2028 ➔ Sep 2026 | Active, not recruiting ➔ Terminated | Trial primary completion date: Dec 2028 ➔ Sep 2026; AMGEN, due to a change in priorities within the Tarlatamab programme, has decided to withdraw its support for the study, which means the clinical trial will be terminated early.

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Endocrine Cancer • Gastrointestinal Cancer • Gastrointestinal Neuroendocrine Carcinoma • Neuroendocrine Carcinoma • Oncology • Solid Tumor • DLL3

TORCH-PM02: FAPI-Guided Radiotherapy With Cadonilimab and Standard Chemotherapy for Colorectal Peritoneal Metastasis: A Phase III Randomized Controlled Trial (TORHC-PM02) (clinicaltrials.gov) - P3 | N=198 | Not yet recruiting | Sponsor: Fudan University

New P3 trial • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor • MSI

RAGNAR: Refractory Advanced diGestive Neuroendocrine Carcinomas Treated With tARlatamab (clinicaltrials.gov) - P2 | N=87 | Active, not recruiting | Sponsor: Grupo Espanol de Tumores Neuroendocrinos | Recruiting ➔ Active, not recruiting

Enrollment closed • Endocrine Cancer • Gastrointestinal Cancer • Gastrointestinal Neuroendocrine Carcinoma • Neuroendocrine Carcinoma • Oncology • Solid Tumor • DLL3

Amivantamab plus FOLFOX or FOLFIRI in metastatic colorectal cancer: Results from OrigAMI-1, an open-label, phase Ib/II study (ESMO 2024) - P1/2 | "With its unique mechanism of action, ami may offer improved efficacy and manageable safety when combined with FOLFOX or FOLFIRI. OrigAMI-1 (NCT05379595) is assessing the safety and efficacy of ami (1050 mg [1400 mg if ≥80kg]) plus mFOLFOX6 or FOLFIRI in anti-EGFR-naïve RAS/RAF WT mCRC... Ami+chemotherapy demonstrated encouraging, durable antitumor activity and a manageable safety profile in anti-EGFR-naïve RAS/RAF WT mCRC."

Clinical • Metastases • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • NRAS

Amivantamab with or without chemotherapy in right-sided metastatic colorectal cancer: Updated results from OrigAMI-1, an open-label, phase 1b/2 study. (ASCO-GI 2025) - P1/2 | "Ami monotherapy or combined with FOLFOX or FOLFIRI demonstrated durable antitumor activity in R-sided mCRC. Efficacy.aAll 3 responders remain on treatment; 2 of 3 responders are ongoing response."

Clinical • Metastases • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • HER-2 • KRAS • MET • NRAS

Amivantamab monotherapy in relapsed/refractory metastatic colorectal cancer: OrigAMI-1, an open-label, phase 1b/2 study. (ASCO-GI 2024) - P1/2 | "Ami plus FOLFOX or FOLFIRI is being explored in additional cohorts...Median age was 60 years, 66% were male, and median prior lines of therapy were 2, with 94% receiving prior bevacizumab and 69% prior anti-EGFR therapy... Ami monotherapy demonstrated promising, durable antitumor activity in refractory mCRC, including pts treated with prior anti-EGFR therapy and pts with right-sided disease. The safety profile of ami in mCRC is manageable and consistent with prior NSCLC experience. Clinical trial information: NCT05379595."

Clinical • Metastases • Monotherapy • P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • ALK • BRAF • EML4 • HER-2 • KRAS • MET • NRAS • PTEN

A p53R273H-selective bispecific T cell engager: Computational design and functional validation. (PubMed, Mol Ther Oncol) - "In 3D model, monotherapy with TCE01Cr3 eliminated >80% of p53R273H-expressing colorectal cancer cells within 48 h while sparing non-malignant stroma, independent of chemotherapy potentiation (oxaliplatin or irinotecan). This off-the-shelf TCE provides a framework for precision immunotherapy in HLA-C∗01:02-positive patients with p53R273H tumors."

IO biomarker • Journal • Colorectal Cancer • Oncology • Solid Tumor • HLA-C • TP53

GLP-1 RA Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer (clinicaltrials.gov) - P1 | N=30 | Recruiting | Sponsor: University of Arizona | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2026 ➔ Oct 2026

Enrollment open • Trial initiation date • Colorectal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

FALCON: Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: University of Oklahoma

New P1 trial • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Fruquintinib Combined With mFOLFOX6/FOLFIRI in First-line Treatment for Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=43 | Completed | Sponsor: Zhou Fuxiang | Recruiting ➔ Completed

Trial completion • Colorectal Cancer • Oncology • Solid Tumor • BRAF

Panc 004: Neoadjuvant Avutometinib/Defactinib and mFOLFIRINOX Combination Therapy in Pancreatic Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=31 | Not yet recruiting | Sponsor: University of Virginia

New P1/2 trial • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor

Neoadjuvant Radiotherapy Combined With NALIRIFOX and Adebrelimab in pMMR/MSS Locally Advanced Rectal Cancer: A Prospective, Randomized, Phase II Clinical Trial (clinicaltrials.gov) - P2 | N=84 | Recruiting | Sponsor: Sun Yat-sen University | Not yet recruiting ➔ Recruiting

Enrollment open • pMMR • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

Epigallocatechin-3-Gallate, the green tea polyphenol suppresses expression of CD31 and VEGFR2 and enhances the chemotherapeutic potential of irinotecan in AOM/DSS model of colorectal cancer in mice. (PubMed, J Egypt Natl Canc Inst) - "Combined treatment of epigallocatechin-3-gallate with irinotecan enhanced the anti-tumour potential of irinotecan, and inhibited cancer progression and expression of tumour-associated angiogenesis markers. Moreover, treatment associated liver injury was also reduced by epigallocatechin-3-gallate supplementation."

Journal • Preclinical • Colorectal Cancer • Hepatology • Liver Failure • Mucositis • Oncology • Solid Tumor • CD31 • KDR • PECAM1

Rapid Administration Pilot for Infusing Dinutuximab (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: Children's Hospital Los Angeles | Phase classification: P1 ➔ P2 | N=11 ➔ 30 | Trial completion date: Jan 2026 ➔ Nov 2029 | Trial primary completion date: Jan 2026 ➔ Nov 2028

Enrollment change • Phase classification • Trial completion date • Trial primary completion date • Neuroblastoma • Oncology • Solid Tumor

Clinical activity of platinum rechallenge with nedaplatin plus irinotecan in recurrent cervical cancer following prior platinum-based systemic chemotherapy: a single-center retrospective study. (PubMed, Int J Clin Oncol) - "Nedaplatin plus irinotecan demonstrated clinically meaningful activity with manageable toxicity in selected patients with recurrent cervical cancer following prior platinum-based systemic chemotherapy. Platinum rechallenge may be a potential treatment option in this setting, although further studies are warranted to identify patients most likely to benefit."

Journal • Retrospective data • Cervical Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia

A phase II study of FOLFIRINOX (FFX) combined with the glycogen synthase kinase-3beta (GSK-3β) inhibitor elraglusib (ELRA) and the transforming growth factor beta (TGFβ) inhibitor losartan (LOS) in patients with untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). (ASCO 2026) - P2 | "Although clinical outcomes with the novel combinations did not exceed historical standards of care, this non-comparator phase II study demonstrates the feasibility and tolerability of combinatorial pathway inhibition in mPDAC. This study enables ongoing correlative analyses of EMT plasticity, stromal remodeling, and immune escape in mPDAC and establishes a robust platform to define determinants of resistance and durable response."

Clinical • Metastases • P2 data • Fibrosis • Infectious Disease • Oncology • Pancreatic Ductal Adenocarcinoma • Septic Shock • TGFB1

First-Line Systemic Treatment for Initially Unresectable Colorectal Liver Metastases: Post Hoc Analysis of the CAIRO5 Randomized Clinical Trial. (PubMed, JAMA Oncol) - P3 | "In patients with colorectal cancer and unresectable liver-only metastases (CRLM), treatment with folinic acid, fluorouracil, and oxaliplatin (FOLFOX) plus irinotecan (FOLFOXIRI) and bevacizumab vs FOLFOX/folinic acid, fluorouracil, and irinotecan (FOLFIRI) plus bevacizumab increased progression-free survival, response, and R0/R1 resection/ablation rates, as well as toxic effects in RAS/BRAFV600E-variant and/or right-sided tumors...To present long-term outcomes of treatment with FOLFOXIRI plus bevacizumab vs FOLFOX/FOLFIRI plus bevacizumab and FOLFOX/FOLFIRI plus panitumumab vs FOLFOX/FOLFIRI + bevacizumab...ACT might be considered for these patients. ClinicalTrials.gov NCT02162563."

Clinical • Journal • Retrospective data • Colorectal Cancer • Oncology • Solid Tumor

Leveraging artificial intelligence to predict immune checkpoint inhibitor (ICI) efficacy in proficient MMR mCRC: Translational analyses of AtezoTRIBE and AVETRIC trials (ESMO 2025) - P2 | "Methods Lunit SCOPE IO quantified the density of lymphocytes (LC), fibroblasts (FB), macrophages (MP), tumor (TC), endothelial (EC) and mitotic (MTC) cells in cancer area (CA) and stroma (CS) on pre-treatment H&E WSIs from pts with pMMR mCRC enrolled in AtezoTRIBE (FOLFOXIRI/bevacizumab +/- atezolizumab [atezo]) and AVETRIC (FOLFOXIRI/cetuximab/avelumab) trials...In the AVETRIC cohort, WSIs from 48 pts were analyzed; 36 (75%) cases were classified as biomarker- high , with better PFS ( P = .043) and OS ( P = .053) compared to biomarker- low ones. Conclusions Our AI-derived tumour microenvironment biomarker may help to predict benefit from ICI-based treatments in pMMR mCRC, supporting further investigations of AI-powered approaches."

Checkpoint inhibition • Clinical • IO biomarker • Colorectal Cancer • Oncology

SARC037: Results of phase I study of trabectedin given as a 1-hour (h) infusion in combination with low dose irinotecan in relapsed/refractory Ewing sarcoma (ES). (ASCO 2023) - P1/2 | "T+I can be safely administered to heavily pretreated pts with ES, demonstrating activity at the RD with 3 PRs (n=5 evaluable). The 18F-FLT PET may be useful to understand patterns of disease progression in ES. Correlative studies will be critical to understanding the mechanism of drug activity."

Combination therapy • P1 data • Anemia • Ewing Sarcoma • Febrile Neutropenia • Hematological Disorders • Neutropenia • Oncology • Sarcoma • Solid Tumor • Thrombocytopenia • FLI1

Plasma ctDNA methylation haplotype profiling as a predictive biomarker for FOLFIRINOX response in pancreatic ductal adenocarcinoma (ESMO 2026) - No abstract available

Biomarker • Circulating tumor DNA • Oncology • Pancreatic Ductal Adenocarcinoma

NRG Oncology/RTOG 0848: Results after adjuvant chemotherapy +/- chemoradiation for patients with resected periampullary pancreatic adenocarcinoma (PA). (ASCO 2024) - P3 | "Background: If 5FU/Capecitabine sensitized radiotherapy (RT) is beneficial in the adjuvant (adj) management of PA after adj chemotherapy (chemo) is controversial...Step 1 rndmzd patients (pts) to 5 cycles of gemcitabine +/- Erlotinib...Step 2 eligibility included > 4 cycles chemo (gem, gem combo, (m)FOLFIRINOX)... Chemo+CRT did not improve OS overall, but did improve DFS. Both OS and DFS were improved with Chemo+CRT in node negative pts. Chemo+CRT did not increase Gr 4 or 5 AEs compared to chemo."

Clinical • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • CA 19-9

A pilot induction regimen incorporating dinutuximab and sargramostim for the treatment of newly diagnosed high-risk neuroblastoma: A report from the Children's Oncology Group. (ASCO 2022) - P2 | "Chemoimmunotherapy including irinotecan, temozolomide, DIN and sargramostim (GM-CSF) in patients with recurrent or refractory neuroblastoma results in robust objective clinical responses. The administration of DIN and GM-CSF to COG Induction Cycles 3-5 for patients with newly-diagnosed high-risk neuroblastoma was tolerable and feasible. The objective response rate at EOI appears encouraging. This therapeutic regimen will be studied in a randomized phase 3 trial to further evaluate the efficacy of Induction phase chemoimmunotherapy for high-risk neuroblastoma."

Clinical • Hypotension • Neuroblastoma • Oncology • Pain • Solid Tumor • CSF2