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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

NCT04674956 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 401

Last updated 2024-04-02

No results posted yet for this study

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.

Conditions

  • Pancreatic Cancer Stage IV
  • Pancreatic Cancer Metastatic

Interventions

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.

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-04
Primary Completion
2024-12-31
Completion
2025-12-31

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04674956 on ClinicalTrials.gov