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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShanghai Shengdi Pharmaceutical Co., Ltd

About this trial

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

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • SHR-1316 Injection
  • Cisplatin Injection
  • Carboplatin Injection
  • Paclitaxel Injection
  • SHR-1316 Placebo Injection

Treatment groups

720 Participants
are divided into 2 treatment groups