Effectiveness and Safety of Camrelizumab Combined With Concurrent Chemoradiotherapy for FIGO IB2-IIIB Cervical Cancer: A Single-center, Single-arm, Open-phase II Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed cervical adenocarcinoma, cervical squamous cell carcinoma, or cervical adenosquamous carcinoma and FIGO2018 IB2 to IIIB;

• Have not received radiotherapy, chemoradiotherapy or other'system therapy for,cervical,cancer in the past.

• With measurable tumor lesions (meet RECIST 1.1 standard).

• Age≥18 years old when signing the informed consent, female.

• ECOG PS: 0-2 points.

• Expected survival time \> 6 months.

• According with lab testing criteria in the protocol.

• Ability and willingness to comply with research and follow-up procedures.

• Females of childbearing potential must agree to use adequate contraception throughout the study period and for 6 months after the end of treatment.

⁃ The patients voluntarily joined the clinical study and signed the informed consent, with good compliance and follow-up.

Locations
Other Locations
China
Lei Li
RECRUITING
Beijing
Contact Information
Primary
Lei Li, M.D.
lileigh@163.com
86-139-1198-8831
Time Frame
Start Date: 2022-03-27
Estimated Completion Date: 2026-03-27
Participants
Target number of participants: 92
Treatments
Experimental: Patients with primary IB2-IIIB cervical cancer
Patients with primary IB2-IIIB cervical cancer, including squamous carcinoma, adenocarcinoma, and adenosquamous carcinoma.
Related Therapeutic Areas
Sponsors
Leads: Lei Li

This content was sourced from clinicaltrials.gov