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

Shanghai Shengdi Pharmaceutical

Status and phase: Enrolling; Phase 3

Conditions: Advanced Cervical Cancer

Treatments: Drug: Cisplatin Injection; Drug: Paclitaxel Injection; Drug: SHR-1316 Placebo Injection; Drug: Carboplatin Injection; Drug: SHR-1316 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07168200

SHR-1316-305

Details and patient eligibility

About

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).

Enrollment: 720 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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720 participants in 2 patient groups, including a placebo group

SHR-1316 Group

Experimental group

Treatment:

Drug: SHR-1316 Injection

Drug: Carboplatin Injection

Drug: Paclitaxel Injection

Drug: Cisplatin Injection

SHR-1316 Placebo Group

Placebo Comparator group

Treatment:

Drug: Carboplatin Injection

Drug: SHR-1316 Placebo Injection

Drug: Paclitaxel Injection

Drug: Cisplatin Injection