NCT07168200 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
| NCT ID | NCT07168200 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Shanghai Shengdi Pharmaceutical Co., Ltd |
| Condition | Advanced Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 720 participants |
| Start Date | 2025-10-17 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 720 participants in total. It began in 2025-10-17 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 by evaluating progression-free survival (PFS).
Eligibility Criteria
Inclusion Criteria: 1. Participate in the study voluntarily, sign the informed consent form. 2. Subjects were able to provide primary or metastatic cancer samples. 3. At least one measurable lesion. 4. Expected survival \> 3 months. 5. ECOG 0 \~ 1. 6. With adequate organ functions. Exclusion Criteria: 1. Pathologically or radiologically confirmed presence of distant metastatic disease, including lymph nodes above the first lumbar vertebra (L1) (cephalad) or in the inguinal region. 2. Administering live vaccines within 4 weeks before enrollment or during planned study treatment. 3. Participants who received immunosuppressive therapy within 4 weeks before enrolment. 4. For participants who are receiving thrombolytic/anticoagulant therapy, prophylactic anticoagulant therapy is allowed. 5. 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. 6. Known allergy to the investigational drug or any of its excipients; or severe allergic reaction to other monoclonal antibodies. 7. Pregnant or breastfeeding women. 8. 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07168200 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Advanced Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07168200 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 720 participants.
Is NCT07168200 currently recruiting?
Yes, NCT07168200 is actively recruiting participants. Contact the research team at xiaoxu.zhang@hengrui.com for enrollment information.
Where is the NCT07168200 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07168200 clinical trial?
NCT07168200 is sponsored by Shanghai Shengdi Pharmaceutical Co., Ltd. The trial plans to enroll 720 participants.
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