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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

ConditionAdvanced 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SHR-1316 Injection

    Drug

    SHR-1316 injection.

  • Cisplatin Injection

    Drug

    Cisplatin injection.

  • Carboplatin Injection

    Drug

    Carboplatin injection.

  • Paclitaxel Injection

    Drug

    Paclitaxel injection.

  • SHR-1316 Placebo Injection

    Drug

    SHR-1316 placebo injection.

Treatment groups

720 Participants
are divided into 2 treatment groups
Group A: SHR-1316 GroupExperimental treatment 4 interventions
Group B: SHR-1316 Placebo GroupPlacebo comparator 4 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Time frame
Up to approximately 36 months.

Secondary outcomes

1

Overall survival (OS)

OS is the time interval from the start of treatment to death due to any reason or lost of follow-up.

Time frame
Up to approximately 60 months.
2

3-year overall survival (OS) rate

OS rate within 3 years.

Time frame
Up to approximately 60 months.
3

2-year progression-free survival (PFS)

PFS within 2 years.

Time frame
Up to approximately 24 months.
4

Objective Response Rate (ORR)

Time frame
Up to approximately 36 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shanghai Shengdi Pharmaceutical Co., Ltd

Lead sponsor

Source ClinicalTrials.gov
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