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

Lei Li1 site in 1 country92 target enrollmentMarch 27, 2022

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

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cervical Carcinoma
Sponsor: Lei Li
Enrollment: 92
Locations: 1
Primary Endpoint: 3-year OS rate
Status: Recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 27, 2022

End Date

March 27, 2026

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Lei Li

Responsible Party

Sponsor Investigator

Principal Investigator

Lei Li

Professor

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•Have previously received an anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-CTLA-4 antibody (or any other antibody that acts on T cell costimulation or checkpoint pathways);
•Have a clear history of allergies, and may have potential allergies or intolerances to the study drug and its similar biological agents.
•Participated in clinical trials of other antitumor drugs within 4 weeks before the first dose, or planned to receive live attenuated vaccines within 4 weeks before the first dose or during the study.
•Other malignant tumors have occurred within 5 years (except for adequately treated cutaneous squamous cell carcinoma or controlled cutaneous basal cell carcinoma).
•Use immunosuppressive medications, excluding nasal and inhaled corticosteroids or physiologic doses of systemic steroids (no more than 10 mg/day prednisolone or other corticosteroids at equivalent doses),within 14 days of first use of camrelizumab.
•Symptomatic advanced patients with visceral dissemination who are at short-term risk of life-threatening complications (including uncontrolled massive exudates \[thoracic, pericardium, abdominal\], pulmonary lymphangitis and more than 30% patients with liver involvement).
•Presence or history of any active autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, no need for any after adulthood Asthma patients who need bronchodilator for medical intervention can not be included).
•Subjects with grade II or higher myocardial ischemia or myocardial infarction, and poorly controlled arrhythmias (including QTc interval ≥450ms in men and ≥470ms in women). According to the New York Heart Association standard, Subjects with grade III-IV cardiac insufficiency, or echocardiography showed left ventricular ejection fraction (LVEF) \<50%; myocardial infarction occurred within 6 months before enrollment, and New York Heart Association grade II or above cardiac function Failure, uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinically significant pericardial disease, or electrocardiogram suggesting acute ischemia or active conduction system abnormalities.
•Concurrent severe infection (eg, requiring intravenous antibiotics, antifungals, or antivirals) within 4 weeks prior to first dose, or unexplained fever \>38.5°C during screening or before first dose.
•Subjects with a history of psychotropic substance abuse and unable to quit or with mental disorders.