Recruiting 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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-1316 Injection, Cisplatin Injection, Carboplatin Injection, Paclitaxel Injection.
- Who it may be relevant to
- Registry conditions: Advanced Cervical Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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).
Interventions
- Drug SHR-1316 Injection
SHR-1316 injection. - Drug Cisplatin Injection
Cisplatin injection. - Drug Carboplatin Injection
Carboplatin injection. - Drug Paclitaxel Injection
Paclitaxel injection. - Drug SHR-1316 Placebo Injection
SHR-1316 placebo injection.
Primary outcome measures
- Progression-free survival (PFS) [Time frame: Up to approximately 36 months.]
Secondary outcome measures (10)
- Overall survival (OS) [Time frame: Up to approximately 60 months.]
- 3-year overall survival (OS) rate [Time frame: Up to approximately 60 months.]
- 2-year progression-free survival (PFS) [Time frame: Up to approximately 24 months.]
- Objective Response Rate (ORR) [Time frame: Up to approximately 36 months.]
- Duration of response (DoR) [Time frame: Up to approximately 60 months.]
- Local recurrence rate [Time frame: Up to approximately 36 months.]
- Distant metastasis rate [Time frame: Up to approximately 60 months.]
- The second disease progression assessed by the investigator [Time frame: Up to approximately 60 months.]
- Adverse events (AEs) including incidence and grade correlation with study drugs [Time frame: Up to approximately 60 months.]
- Rate of suspension and discontinuation due to an adverse event correlation with study drugs [Time frame: Up to approximately 60 months.]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fudan University Shanghai Cancer Center — Shanghai
Identifiers
NCT: NCT07168200 · SHR-1316-305