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

Inclusion Criteria6

  • Participate in the study voluntarily, sign the informed consent form.
  • Subjects were able to provide primary or metastatic cancer samples.
  • At least one measurable lesion.
  • Expected survival \> 3 months.
  • ECOG 0 \~ 1.
  • With adequate organ functions.

Exclusion Criteria8

  • Pathologically or radiologically confirmed presence of distant metastatic disease, including lymph nodes above the first lumbar vertebra (L1) (cephalad) or in the inguinal region.
  • Administering live vaccines within 4 weeks before enrollment or during planned study treatment.
  • Participants who received immunosuppressive therapy within 4 weeks before enrolment.
  • For participants who are receiving thrombolytic/anticoagulant therapy, prophylactic anticoagulant therapy is allowed.
  • Participants who have had other uncured malignant tumors in the past (within 5 years) or concurrently have had other uncured malignant tumors, excluding cured basal cell carcinoma of the skin and carcinoma in situ.
  • Known allergy to the investigational drug or any of its excipients; or severe allergic reaction to other monoclonal antibodies.
  • Pregnant or breastfeeding women.
  • According to the investigator's judgment, there are diseases or any other conditions that may seriously endanger the safety of the subjects, may confound the research results, or affect the subjects' ability to complete the study.

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

View Full Details on ClinicalTrials.gov

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NCT07168200