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
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Advanced Cervical Cancer
In brief
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).
Key facts
- Study ID
- NCT07168200
- Run by
- Shanghai Shengdi Pharmaceutical Co., Ltd
- People needed
- 720
- Starts
- 2025-10-17
- Expected to finish
- 2028-12-01
- Last updated by the study team
- 2026-04-15
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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