irinotecan liposomal / CSPC Pharma - LARVOL DELTA

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

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 | Recruiting | Sponsor: Sun Yat-sen University | N=33 ➔ 68

Enrollment change • Hematological Malignancies • Lymphoma • Oncology • Pediatrics • Solid Tumor

ASCO GI 2023 NAPOLI-3 Randomized, Open-Label Phase 3 Study: Liposomal Irinotecan + 5-Fluorouracil/Leucovorin + Oxaliplatin (NALIRIFOX) vs. nab-Paclitaxel + Gemcitabine in Treatment-Naïve Patients With mPDAC (VuMedi) - https://www.vumedi.com/video/asco-gi-2023-napoli-3-randomized-open-label-phase-3-study-liposomal-irinotecan-5-fluorouracilleucovo/

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