irinotecan hydrochloride liposome injection (HR070803) / Jiangsu Hengrui Pharma - LARVOL DELTA

A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=669 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Colorectal Cancer • Oncology • Solid Tumor

Phase 1 trial of HR070803 (an Irinotecan liposome) in combination with 5-fluorouracil, leucovorin, and oxaliplatin for untreated advanced or metastatic pancreatic ductal adenocarcinoma. (PubMed, BMC Med) - P1 | "HR070803 plus 5-FU/LV and oxaliplatin demonstrated an acceptable toxicity, good antitumor activity, and favorable pharmacokinetic profile as a first-line treatment for patients with unresectable locally advanced or metastatic PDAC. Based on the comprehensive data obtained during the dose escalation and dose expansion stages, HR070803 60 mg/m2 plus 5-FU/LV and oxaliplatin 85 mg/m2 was chosen as the RP2D."

Journal • P1 data • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

The CREAFORMO-004 study: A phase II study of HR070803 plus 5-fluorouracil/leucovorin and bevacizumab as second-line treatment in patients with metastatic colorectal cancer. (ASCO 2025) - P=N/A | " In this phase 2 study (ChiCTR2300075966), patients with histologically confirmed mCRC who had failed prior first-line chemotherapy (fluoropyrimidine plus oxaliplatin, with either bevacizumab or an anti-EGFR antibody for RAS wild-type tumors) were eligible for enrollment. Irinotecan liposome (HR070803) in combination with 5-FU/LV and bevacizumab demonstrated promising efficacy and durability in this patient population. These results support further investigation of irinotecan liposome (HR070803) as a treatment option for patients with mCRC."

Clinical • Metastases • P2 data • Colon Cancer • Colorectal Cancer • Hepatocellular Cancer • Microsatellite Instability • Oncology • Solid Tumor • HER-2 • KRAS • MSI

Phase II Study of Irinotecan Liposome (II) Combined With Temozolomide and Fluzoparib in Recurrent or Metastatic Ewing Sarcoma (clinicaltrials.gov) - P2 | N=29 | Recruiting | Sponsor: Sun Yat-sen University | Not yet recruiting ➔ Recruiting

Enrollment open • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor

Phase II Study of Irinotecan Liposome (II) Combined With Temozolomide and Fluzoparib in Recurrent or Metastatic Ewing Sarcoma (clinicaltrials.gov) - P2 | N=29 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor

Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial. (PubMed, Signal Transduct Target Ther) - P3 | "No treatment-related deaths occurred in the HR070803 group, while the placebo group reported one treatment-related death (abdominal infection). HR070803 in combination with 5-FU/LV has shown promising efficacy and manageable safety in advanced or metastatic PDAC in the second-line setting, representing a potential option in this patient population."

Clinical • Combination therapy • Journal • Metastases • P3 data • Gastrointestinal Cancer • Infectious Disease • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial (Nature) - P3 | N=298 | PAN-HEROIC-1 (NCT05074589) | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | "A total of 298 patients were enrolled and received HR070803 plus 5-FU/LV (HR070803 group, n = 149) or placebo plus 5-FU/LV (placebo group, n = 149). Median OS was significantly improved in the HR070803 group compared to the placebo group (7.4 months [95% CI 6.1–8.4] versus 5.0 months [95% CI 4.3–6.0]; HR 0.63 [95% CI 0.48–0.84]; two-sided p = 0.0019). The most common grade ≥ 3 adverse events in the HR070803 group were increased gamma-glutamyltransferase (19.0% versus 11.6% in placebo group) and decreased neutrophil count (12.9% versus 0 in placebo group). No treatment-related deaths occurred in the HR070803 group, while the placebo group reported one treatment-related death (abdominal infection)."

P3 data • Gastrointestinal Cancer • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Liposomal irinotecan (HR070803) in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors: a phase 1b dose-escalation and expansion study. (PubMed, Invest New Drugs) - P1 | "Retrospectively registered on Oct. 12, 2021."

Combination therapy • Journal • Metastases • P1 data • Anorexia • Fatigue • Febrile Neutropenia • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor

HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov) - P3 | N=778 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | N=522 ➔ 778

Combination therapy • Enrollment change • Metastases • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

HR070803 in Combination With Oxaliplatin, S-1 Versus NALIRIFOX as Adjuvant Therapy for Pancreatic Cancer (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: The First Affiliated Hospital with Nanjing Medical University

Combination therapy • New P2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

HR070803 in Combination With Oxaliplatin, 5-fluorouracil/LV Versus GX as Adjuvant Therapy for Pancreatic Cancer (clinicaltrials.gov) - P3 | N=524 | Not yet recruiting | Sponsor: Fudan University

Combination therapy • New P3 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Hengrui Pharmaceutical's 'Irinotecan Liposome' was approved to treat pancreatic cancer! [Google translation] (163.com) - "On January 1, the official website of the National Medical Products Administration (NMPA) of China announced that the marketing application of irinotecan hydrochloride liposome injection declared by Hengrui Pharmaceutical in registration classification 5.2 has been approved....Based on the results of a phase 2 clinical trial of the product in combination with 5-FU/LV in the second-line treatment of locally advanced or metastatic pancreatic cancer after gemcitabine failure, Hengrui Pharmaceutical submitted a marketing application for the product."

Non-US regulatory • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=606 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase II/III Study of HR070803 in Combination With Oxaliplatin, 5-fluorouracil, Calcium Folinate and Bevacizumab Versus FOLFOX in Combination With Bevacizumab for First-line Treatment of Advanced Colorectal Cancer (clinicaltrials.gov) - P2/3 | N=606 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Combination therapy • Metastases • New P2/3 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov) - P3 | N=522 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Cetuximab retreatment plus camrelizumab and liposomal irinotecan in patients with RAS wild-type metastatic colorectal cancer: Cohort B of the phase II CRACK study. (PubMed, Int J Cancer) - "No grade ≥4 TRAEs were found in the safety population. Our study suggests that anti-EGFR retreatment therapy with cetuximab plus camrelizumab and liposomal irinotecan (HR070803) is a promising late-line treatment option with good antitumor activity and well-tolerated toxicity in RASwt mCRC patients."

Journal • Metastases • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • RAS

HR070803 in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Advanced Pancreatic Cancer (clinicaltrials.gov) - P3 | N=522 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Combination therapy • Metastases • New P3 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

HR070803 plus 5-FU/LV versus placebo plus 5-FU/LV in second-line therapy for gemcitabine-refractory locally advanced or metastatic pancreatic cancer: A multicentered, randomized, double-blind, parallel-controlled phase III trial (HR-IRI-APC) (ESMO 2022) - P3 | "Randomization was stratified by serum albumin level, treatment history of fluorouracil, treatment history of gemcitabine. The incidence of all grade and grade≥3 diarrhea was 45.58% and 4.08%, neutropenia was 33.33% and 12.93%, cholinergic syndrome was 1.36% and 0% in arm A. Conclusions HR070803 plus 5-FU/LV demonstrated a highly statistically significant and clinically meaningful improvement in OS in treatment of locally advanced or metastatic PC with prior gemcitabine-based therapy. Along with a manageable safety profile, these data suggest HR070803 plus 5-FU/LV is a new treatment selection for the population."

Clinical • Late-breaking abstract • P3 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A Phase II Study of HR070803 in the Treatment of Advanced Esophageal Cancer (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Esophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor