Status:
RECRUITING
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
Lead Sponsor:
Shanghai Shengdi Pharmaceutical Co., Ltd
Conditions:
Advanced Cervical Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
720 Patients enrolled
Trial Details
Trial ID
NCT07168200
Start Date
October 17 2025
End Date
December 1 2028
Last Update
November 17 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032