PD-1 Antibody Plus Chemoradiotherapy for IB2-IIIB Cervical Cancer

Sponsor
Lei Li
Study ID
NCT05311566
Phase
PHASE2
Status
Unknown

Conditions

  • Adverse Events
  • Anti-programmed Cell Death Receptor 1
  • Cervical Carcinoma
  • Chemoradiotherapy
  • Early Stage Cervical Cancer
  • Immune Checkpoint Inhibitor
  • Immunotherapy
  • Locally Advanced Cervical Cancer
  • Survival Outcomes

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab plus Concurrent chemoradiotherapy — COMBINATION_PRODUCT
    Participants will be given intravenous administration of Camrelizumab (200mg，every 2 weeks),Cisplatin(40mg/m²，everyweek) and Radiotherapy. After completing 6\~8weeks of concurrent chemoradiation, the Participants will continue to use camrelizumab as maintenance therapy until disease progression or unacceptable toxicity.

Study Details

This study is a single-center, single-arm, open-phase II clinical study, the main purpose of which is to evaluate the effectiveness and safety of camrelizumab combined with concurrent chemoradiotherapy for early and locally advanced cervical cancer, i.e., FIGO 2018 IB2-IIIB cervical cancer. Eligible subjects will be given cisplatin and radiotherapy, for 6-8 weeks, camrelizumab repeated every 14 days until disease progression, toxicity intolerance, or other reasons specified in the protocol. Subjects who finished treatment entered the safety follow-up or survival follow-up.

Key Dates

Start date
Mar 27, 2022
Status verified
Apr 2022
Primary completion
Mar 27, 2023
Completion
Mar 27, 2026

Study Design

Enrollment
92 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with primary IB2-IIIB cervical cancer
    Patients with primary IB2-IIIB cervical cancer, including squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma.

Primary Outcome Measure

3-year OS rate [ Time Frame: 36 months ]

Central Contacts

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