RecruitingPhase 3NCT04674956

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


Sponsor

RenJi Hospital

Enrollment

401 participants

Start Date

Mar 4, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of an immunotherapy drug (camrelizumab, an anti-PD1 antibody) with two chemotherapy drugs (albumin-bound paclitaxel and gemcitabine) as a first-line treatment for patients with metastatic pancreatic cancer. Researchers want to find out whether adding immunotherapy to standard chemotherapy improves outcomes. **You may be eligible if you:** - Are 18 years of age or older - Have confirmed metastatic pancreatic adenocarcinoma (pancreatic cancer that has spread) - Have not received any prior systemic (whole-body) cancer treatment - Have measurable disease on scans - Are in good health (ECOG 0–1) - Have an expected survival of at least 12 weeks - Have adequate organ function (blood, liver, kidneys) **You may NOT be eligible if you:** - Have previously been treated with chemotherapy or other systemic therapy for this cancer - Have poor organ function that would make the treatment unsafe - Are unable to tolerate the study drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCamrelizumab

PD-1 antibody(Camrelizumab), 200mg, D1; every 21 days as a cycle.

DRUGPaclitaxel(Albumin Bound) and Gemcitabine

Paclitaxel(Albumin Bound), 125 mg/m2D18; Gemcitabine, 1000mg/m2D1, 8;every 21 days as a cycle.

DRUGPlacebo

Placebo, 200mg, D1; every 21 days as a cycle.


Locations(6)

Ruijin hospital

Shanghai, Shanghai Municipality, China

Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Renji hospital

Shanghai, Shanghai Municipality, China

Changhai Hospital

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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NCT04674956


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