RecruitingPhase 3NCT07168200

A Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer

A Randomized, Controlled, Double-blind, Multicenter Phase III Clinical Study of Adebrelimab Combined With Concurrent Chemoradiotherapy Versus Placebo Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced Cervical Cancer


Sponsor

Shanghai Shengdi Pharmaceutical Co., Ltd

Enrollment

720 participants

Start Date

Oct 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to evaluate the efficacy of Adebrelimab plus concurrent chemoradiotherapy compared with placebo plus concurrent chemoradiotherapy for the treatment of locally advanced cervical cancer by evaluating progression-free survival (PFS).


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase III trial is testing whether adding an immunotherapy drug (adebrelimab) to standard chemoradiotherapy (combined chemotherapy and radiation) works better than chemoradiotherapy alone for locally advanced cervical cancer. The study focuses on patients with measurable tumors who have not had surgery. **You may be eligible if...** - You have locally advanced cervical cancer with at least one measurable lesion - You are in reasonably good health (ECOG 0 or 1) - You have adequate organ function (blood counts, liver, kidneys) - You are expected to survive at least 3 months **You may NOT be eligible if...** - Your cancer has spread to distant lymph nodes (above lumbar spine level L1) or to the groin area - You have received live vaccines within the past 4 weeks - You are on immune-suppressing medications - You have had prior immunotherapy for cervical cancer - You are pregnant or breastfeeding 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

DRUGSHR-1316 Injection

SHR-1316 injection.

DRUGCisplatin Injection

Cisplatin injection.

DRUGCarboplatin Injection

Carboplatin injection.

DRUGPaclitaxel Injection

Paclitaxel injection.

DRUGSHR-1316 Placebo Injection

SHR-1316 placebo injection.


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT07168200