irinotecan liposomal / CSPC Pharma - LARVOL DELTA

NALIRIFOX versus gemcitabine plus nab-paclitaxel in Chinese patients with advanced pancreatic adenocarcinoma: a randomized, open-label phase II trial. (PubMed, Nat Commun) - P2 | "In this phase 2 study (NCT05047991), patients with unresectable metastatic pancreatic adenocarcinoma were randomized to receive NALIRIFOX (liposomal irinotecan, 5-FU, leucovorin, and oxaliplatin) or gemcitabine plus nab-paclitaxel...≥ Grade 3 treatment-emergent adverse events (TEAEs) occurred in 73.1% of patients receiving NALIRIFOX and 84.6% of patients receiving gemcitabine plus nab-paclitaxel, respectively. Despite the premature termination (predetermined sample size of n = 153 not reached) of the study, NALIRIFOX demonstrated improvement in PFS compared with gemcitabine plus nab-paclitaxel, with a manageable safety profile in Chinese patients with advanced pancreatic adenocarcinoma."

Journal • P2 data • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • UGT1A1

Intraperitoneal Injection of Liposomal Irinotecan as Monotherapy or in Combination With Recombinant Mutant Human Tumor Necrosis Factor or Bevacizumab for the Treatment of Malignant Ascites Following Failure of Prior Standard Therapy (clinicaltrials.gov) - P1/2 | N=48 | Recruiting | Sponsor: Dong sheng Zhang

Monotherapy • New P1/2 trial • Gastrointestinal Cancer

Irinotecan hydrochloride liposome injection combined with oxaliplatin and 5-FU/LV for the treatment of liver metastasis from advanced pancreatic cancer: A multicenter, open-access, Phase II exploratory study (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: China-Japan Friendship Hospital; China-Japan Friendship Hospital

New P2 trial • Oncology • Pancreatic Cancer • Solid Tumor

A phase II study of simmitinib in combination with liposomal irinotecan for second-line treatment of advanced esophageal squamous cell carcinoma (ESMO 2025) - P2 | "Two treatment-related deaths (both in arm 1) were attributed to small bowel obstruction with infection and hematemesis. Table: 2125P n (%) Arm 1 (N = 22) Arm 2 (N = 14) Arm 3 (N = 5) Any grade TRAEs 20 (90.9%) 14 (100%) 5 (100%) Grade ≥3 TRAEs 9 (40.9%) 6 (42.9%) 3 (60.0%) Diarrhea 2 (9.1%) 1 (7.1%) 0 Vomiting 2 (9.1%) 0 0 Hyponatremia 2 (9.1%) 1 (7.1%) 0 Leukopenia 2 (9.1%) 1 (7.1%) 1 (20.0%) Nausea 1 (4.5%) 1 (7.1%) 1 (20.0%) Hematemesis 1 (4.5%) 0 0 Esophagomediastinal fistula 1 (4.5%) 0 0 Small bowel obstruction 1 (4.5%) 0 0 Neutropenia 1 (4.5%) 1 (7.1%) 2 (40.0%) Febrile neutropenia 1 (4.5%) 0 0 Anemia 1 (4.5%) 1 (7.1%) 0 Hypochloremia 1 (4.5%) 0 0 Hypertriglyceridemia 1 (4.5%) 0 0 Decreased appetite 1 (4.5%) 0 0 Infection 1 (4.5%) 0 0 Hypertension 1 (4.5%) 0 0 Fatigue 0 2 (14.3%) 0 Elevation of γ-GT 0 1 (7.1%) 0 Elevation of s-ALP 0 1 (7.1%) 0 Conclusions Simmitinib in combination with liposomal irinotecan demonstrated promising efficacy in patients with ESCC,..."

Clinical • Combination therapy • Metastases • P2 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

A prospective, single-arm phase II clinical study of liposomal irinotecan in combination with interleukin-2 and sintilimab in the second-line treatment of patients with advanced gastric cancer (ChiCTR) - P1 | N=45 | Not yet recruiting | Sponsor: Gaoxin Hospital of The First Affiliated Hospital of Nanchang University; Gaoxin Hospital of The First Affiliated Hospital of Nanchang University

New P1 trial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Phase I/II exploratory study of irinotecan liposome + capecitabine + oxaliplatin in the treatment of patients with borderline resectable/locally advanced pancreatic cancer (ChiCTR) - P1/2 | N=48 | Not yet recruiting | Sponsor: Peking University First Hospital; Peking University First Hospital

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

Phase II Study of Irinotecan Liposomes Combined With 5-FU/LV+ Bevacizumab in First-line Treatment of Metastatic Colorectal Cancer (ChiCTR) - P2 | N=86 | Completed | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

New P2 trial • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • BRAF

A Irinotecan Liposome Trial of in Advanced Neuroendocrine Carcinoma (clinicaltrials.gov) - P4 | N=45 | Not yet recruiting | Sponsor: Beijing GoBroad Hospital

New P4 trial • Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

Irinotecan Liposomes with Capecitabine and Bevacizumab for the Elderly Colorectal Cancer Patients Failed to Oxaliplatin-based Regimen: The LIVE Study (ChiCTR) - P4 | N=31 | Not yet recruiting | Sponsor: The Affiliated Hospital of Fudan University, Hua Shan; The Affiliated Hospital of Fudan University, Hua Shan

New P4 trial • Colorectal Cancer • Oncology • Solid Tumor • MSI

Irinotecan liposome combined with capecitabine + sintilimab +/- bevacizumab as first-line therapy for patients with RAS mutation and MSS-type metastatic colorectal cancer (ChiCTR) - P2 | N=30 | Not yet recruiting | Sponsor: Sichuan Cancer Hospital; Sichuan Cancer Hospital

New P2 trial • Colorectal Cancer • Oncology • Solid Tumor • BRAF

The efficacy and safety research of irinotecan liposome injection combined with 5-FU/LV for HAIC+- Sindillizumab and Bevacizumab in the treatment of unresectable advanced biliary tract cancer (ChiCTR) - P=N/A | N=30 | Sponsor: Affiliation Hospital of JiangNan University; Affiliation Hospital of JiangNan University

New trial • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Oncology • Solid Tumor

A Study on Irinotecan Liposome Injection for Neoadjuvant Treatment of Colorectal Cancer Patients (ChiCTR) - P2 | N=30 | Recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P2 trial • Colon Cancer • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor

Phase I clinical study of irinotecan liposome combined with furoquininib in the third-line and beyond patients with advanced colorectal cancer (ChiCTR) - P1 | N=18 | Sponsor: Guangxi Medical University Cancer Hospital; Guangxi Medical University Cancer Hospital

New P1 trial • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor

Single-arm, multicenter, exploratory clinical study of irinotecan liposomes combined with oxaliplatin and 5-Fu/Lv in second-line treatment of locally advanced or metastatic pancreatic cancer (ChiCTR) - P4 | N=38 | Sponsor: Wuxi People's Hospital; Wuxi People's Hospital

New P4 trial • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Liposomal Irinotecan in Combination With Oxaliplatin and S-1 Versus Gemcitabine Combined With Capecitabine as Postoperative Adjuvant Therapy for Pancreatic Cancer (clinicaltrials.gov) - P3 | N=408 | Not yet recruiting | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

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

Study of Irinotecan Liposome Injection in Patients With Advanced Breast Cance (clinicaltrials.gov) - P1 | N=119 | Completed | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed

Metastases • Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2 • HER-2 • PD-L1 • TOP1 • UGT1A1

Study of Irinotecan Liposome Injection in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=17 | Terminated | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. | N=66 ➔ 17 | Not yet recruiting ➔ Terminated; Internal strategy change. Not related to safety concerns.

Enrollment change • Metastases • Trial termination • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Solid Tumor

Phase I Dose Escalation and Pharmacokinetics Clinical Trial of Mitoxantrone Hydrochloride Liposome in Children With Relapsed and Refractory Lymphoma and Solid Tumors (clinicaltrials.gov) - P1 | N=68 | Active, not recruiting | Sponsor: Sun Yat-sen University | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2024 ➔ Sep 2024

Enrollment closed • Trial primary completion date • Hematological Malignancies • Lymphoma • Oncology • Pediatrics • Solid Tumor

Study of Irinotecan Liposome Injection as Second-line Regimen in Patients With Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - P2 | N=66 | Completed | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A phase II study of liposomal irinotecan-based chemotherapy with or without PD-1 inhibitor in patients with unresectable locally advanced or metastatic biliary tract cancer. (ASCO 2024) - "It was used with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic pancreatic cancer progressing on gemcitabine treatment. These preliminary results suggested that liposomal irinotecan plus 5-FU and LV was well-tolerated and showed promising and durable clinical activity in advanced BTC pts progressed on first-line treatment. Combined use of SG001 further improved clinical outcome in these pts without increased toxicity. Combination of liposomal irinotecan, 5-FU, LV and PD-1 inhibitor is a treatment strategy which is worthy of further exploration."

Clinical • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Fatigue • Febrile Neutropenia • Gastrointestinal Cancer • Hematological Disorders • Hepatology • Leukopenia • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor

A randomised phase 2 study of liposomal irinotecan in combination with 5-fluorouracil/leucovorin and oxalipalatin versus nab-paclitaxel plus gemcitabine in unresectable locally advanced or metastatic pancreatic cancer. (ASCO 2024) - P2 | "Patients with unresectable locally advanced or metastatic pancreatic cancer were randomly assigned (2:1) to receive NALIRIFOX (HE072 50 mg/m², oxaliplatin 60 mg/m², leucovorin 400 mg/m², and fluorouracil 2400 mg/m², administered sequentially as a continuous intravenous infusion over 46 h) on days 1 and 15 of a 28-day cycle or AG (nab-paclitaxel 125 mg/m² and gemcitabine 1000 mg/m²), administered intravenously, on days 1, 8, and 15 of a 28-day cycle. The study met the primary endpoint of PFS demonstrating statistically significant and clinically meaningful improvements in PFS and with a trend of OS benefit for NALIRIFOX over AG. The safety profile was consistent with the known risks of the individual toxicity. This study is consistent with the existing NAPOLI 3 study."

Clinical • Combination therapy • Metastases • P2 data • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

A phase 1 study of liposomal irinotecan in patients with advanced breast cancer. (ASCO 2024) - P1 | "Background: Liposomal irinotecan (HE072) is a liposomal formulation that encapsulates irinotecan in a lipid bilayer vesicle, and as a generic drug, had been approved in China, recently, in patients with pancreatic cancer after gemcitabine treatment. HE072 exhibited excellent antitumor activity in heavily pre-treated patients with TNBC and HER2 negative BCBM with acceptable safety profiles. 70 mg/m 2 Q2W was determined as the RP2D. Further clinical trials are under plan."

Clinical • Metastases • P1 data • Anemia • Breast Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Leukopenia • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor • Triple Negative Breast Cancer • HER-2

Irinotecan Liposome Combined With Oxaliplatin and Tegafur as Adjuvant Therapy for Pancreatic Cancer (clinicaltrials.gov) - P=N/A | N=53 | Recruiting | Sponsor: Kuirong Jiang

New trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Efficacy and Safety of Irinotecan Liposome Injection Combined With 5-FU/LV± Immunotherapy in First-line Gemsitabine + Immunoprogressive Patients With Metastatic Biliary Tract Cancer (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Tianjin Medical University Cancer Institute and Hospital

New trial • Biliary Cancer • Biliary Tract Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Dose Escalation and Expansion Clinical Trial of Irinotecan Liposome Combined With Oxaliplatin and 5-FU/LV Plus Bevacizumab as First-line Treatment of Metastatic Colorectal Cancer (clinicaltrials.gov) - P1 | N=78 | Recruiting | Sponsor: Shanghai Zhongshan Hospital

Metastases • New P1 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor