NCT04674956

A Prospective, Randomized, Double-blinded, Multi-center Clinical Trial to Evaluate the Efficiency and Safety of Anti-PD1 Antibody (Camrelizumab) Combined With Paclitaxel(Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer

A Prospective, Randomized, Double-blinded, Multi-center Clinical Trial to Evaluate the Efficiency and Safety of Anti-PD1 Antibody (Camrelizumab) Combined With Paclitaxel(Albumin Bound) and Gemcitabine Versus Paclitaxel(Albumin Bound) and Gemcitabine as First-line Therapy in Patients With Metastatic Pancreatic Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 401 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Aim：Evaluate the efficiency and safety of anti-PD1 antibody (Camrelizumab) combined with Paclitaxel(Albumin Bound) and Gemcitabine as first-line therapy in patients with metastatic pancreatic cancer. Drug information： * anti-PD1 antibody (Camrelizumab) * AG regimens：the standard first-line regimens for metastatic pancreatic cancer.

Detailed description

CPOG1210-07 is a prospective, randomized, double-blinded, multi-center clinical trial in China aiming to evaluate the efficiency and safety of anti-PD1 antibody (Camrelizumab) combined with Paclitaxel(Albumin Bound) and Gemcitabine versus Paclitaxel(Albumin Bound) and Gemcitabine as first-line therapy in patients with metastatic pancreatic cancer. The anti-PD1 antibody(Camrelizumab) is a humanized monoclonal antibody which can specifically bind to PD-1 and block the interaction between PD-1 and its ligand (PD-L1), allowing T cells to recover the immune response against tumors. It is proved to be effective in certain cancers such as ovarian cancers and certification proved by Chinese Food and Drug Administration(CFDA) includes Hodgkin's lymphoma, non-small cell lung cancer, esophageal cancer and liver cancer.

Conditions

• Pancreatic Cancer Stage IV
• Pancreatic Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Camrelizumab	PD-1 antibody（Camrelizumab）, 200mg, D1; every 21 days as a cycle.
DRUG	Paclitaxel(Albumin Bound) and Gemcitabine	Paclitaxel(Albumin Bound), 125 mg/m2D18; Gemcitabine, 1000mg/m2D1, 8;every 21 days as a cycle.
DRUG	Placebo	Placebo, 200mg, D1; every 21 days as a cycle.

Timeline

• Start date: 2021-03-04
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2020-12-19
• Last updated: 2024-04-02

Locations

6 sites across 1 country: China