Adebrelimab plus concurrent chemoradiotherapy versus placebo for 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

This trial will test whether adding adebrelimab to standard concurrent chemoradiotherapy helps people with locally advanced cervical cancer live longer without their cancer getting worse.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 720 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Shanghai Shengdi Pharmaceutical Co., Ltd (Industry-sponsored)
• Drugs / interventions: Adebrelimab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07168200 on ClinicalTrials.gov

What this trial studies

This randomized Phase III trial compares adebrelimab (SHR-1316) given with standard concurrent chemoradiotherapy to placebo combined with the same chemoradiotherapy in people with locally advanced cervical cancer. Participants receive concurrent radiation with platinum- and taxane-based chemotherapy (cisplatin or carboplatin plus paclitaxel) and either adebrelimab or placebo injections. The primary endpoint is progression-free survival, with tumor response and safety monitored during and after treatment. Eligible participants must have a measurable lesion, ECOG performance status 0–1, adequate organ function, and no distant metastatic disease above the L1 vertebra or in the inguinal region.

Who should consider this trial

Good fit: Ideal candidates are people with locally advanced cervical cancer who have at least one measurable lesion, ECOG 0–1, adequate organ function, and no distant metastases above L1 or in the inguinal region.

Not a fit: Patients with confirmed distant metastatic disease (cephalad to L1 or in the inguinal nodes), recent immunosuppressive therapy, recent live vaccines, or other uncured malignancies within five years are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, adding adebrelimab could extend the time patients live without their cancer worsening and potentially improve cure rates for locally advanced disease.

How similar studies have performed: Other immune checkpoint inhibitors have shown benefit in recurrent or metastatic cervical cancer, and combining PD-1/PD-L1 agents with chemoradiotherapy is an active area of research though not yet established as standard for locally advanced disease.

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Xiaoxu Zhang

Conditions Advanced Cervical Cancer