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

NCT05311566 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2022-04-13

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

COMBINATION_PRODUCT

Camrelizumab plus Concurrent chemoradiotherapy

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.

Sponsors & Collaborators

  • Lei Li

    lead OTHER

Principal Investigators

  • Lei Li, M.D. · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-27
Primary Completion
2023-03-27
Completion
2026-03-27

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05311566 on ClinicalTrials.gov