NCT04961788

Anti-PD1 Antibody Toripalimab Combined With Gemox as First-line Therapy in Late-stage Intrahepatic Cholangiocarcinoma

A Phase 2 Study of Anti-PD1 Antibody Toripalimab Combined With Gemox (Gemcitabine and Oxaliplatin) as First-line Therapy in Patients With Advanced or Unresectable Intrahepatic Cholangiocarcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Shanghai Zhongshan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the objective response rate and safety of toripalimab combined with Gemox in the first-line treatment of progressive, metastatic or unresectable advanced ICC.

Detailed description

Studies have shown that the Gemox chemotherapy (oxaliplatin + gemcitabine) in patients with advanced biliary tract cancer has an objective response rate (ORR) of 22% (95% CI 6.5-37.4%) and a stable disease rate of 30%. The progression rate was 48%, the tumor progression-free survival (PFS) was 3.9 months and the overall survival (OS) was 7.6 months. In recent years, monoclonal antibodies against programmed cell death protein 1 (PD1) and programmed cell death ligand 1 (PD-L1) such as nivolumab, Pembrolizumab, and Toripalimab. It has shown encouraging effects in the treatment of a variety of solid tumors. For advanced cholangiocarcinoma that cannot be resected or is accompanied by metastasis, NCCN guidelines (NCCN guidelines hepatobiliary cancer, 2020) recommend that the current treatment options are limited, and gemcitabine combined with platinum anti-tumor drugs (cisplatin, oxaliplatin, etc.) are recommended. Chemotherapy regimen as first-line treatment. For those with microsatellite instability, it is recommended to add a PD1 monoclonal antibody. The guidelines also specifically stated that the above recommendations lack evidence support from phase III clinical trials and encourage the development of clinical trial research. PD1 monoclonal antibody combined with chemotherapy in the treatment of advanced ICC may have a better effect than chemotherapy alone. Currently, as a first-line treatment, there is no research report on PD1 monoclonal antibody combined with Gemox in the treatment of advanced ICC.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DRUG	Gemox combimed PD1 antibody	1. Toripalimab (240mg) intravenously, the administration time is 60 (+15) minutes, Q3W is administered once. 2. Gemox chemotherapy D1: oxaliplatin 85mg/m2, gemcitabine 1g/m2 D8: Gemcitabine 1g/m2 Three weeks is a course of treatment, a total of 6-8 courses.

Timeline

• Start date: 2021-07-01
• Primary completion: 2021-12-31
• Completion: 2022-12-31
• First posted: 2021-07-14
• Last updated: 2021-07-14

Locations

1 site across 1 country: China