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

Last updated: April 5, 2022
Sponsor: Lei Li
Overall Status: Active - Recruiting

Phase

2

Condition

Carcinoma

Cervical Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT05311566
IMURADIO3
  • Ages > 18
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically confirmed cervical adenocarcinoma, cervical squamous cell carcinoma, orcervical adenosquamous carcinoma and FIGO2018 IB2 to IIIB;
  2. Have not received radiotherapy, chemoradiotherapy or other'system therapyfor,cervical,cancer in the past.
  3. With measurable tumor lesions (meet RECIST 1.1 standard).
  4. Age≥18 years old when signing the informed consent, female.
  5. ECOG PS: 0-2 points.
  6. Expected survival time > 6 months.
  7. According with lab testing criteria in the protocol.
  8. Ability and willingness to comply with research and follow-up procedures.
  9. Females of childbearing potential must agree to use adequate contraception throughoutthe study period and for 6 months after the end of treatment.
  10. The patients voluntarily joined the clinical study and signed the informed consent,with good compliance and follow-up.

Exclusion

Exclusion Criteria:

  1. Have previously received an anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2antibody, or anti-CTLA-4 antibody (or any other antibody that acts on T cellcostimulation or checkpoint pathways);
  2. Have a clear history of allergies, and may have potential allergies or intolerances tothe study drug and its similar biological agents.
  3. Participated in clinical trials of other antitumor drugs within 4 weeks before thefirst dose, or planned to receive live attenuated vaccines within 4 weeks before thefirst dose or during the study.
  4. Other malignant tumors have occurred within 5 years (except for adequately treatedcutaneous squamous cell carcinoma or controlled cutaneous basal cell carcinoma).
  5. Use immunosuppressive medications, excluding nasal and inhaled corticosteroids orphysiologic doses of systemic steroids (no more than 10 mg/day prednisolone or othercorticosteroids at equivalent doses),within 14 days of first use of camrelizumab.
  6. Symptomatic advanced patients with visceral dissemination who are at short-term riskof life-threatening complications (including uncontrolled massive exudates [thoracic,pericardium, abdominal], pulmonary lymphangitis and more than 30% patients with liverinvolvement).
  7. 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 withvitiligo or asthma in childhood have been completely relieved, no need for any afteradulthood Asthma patients who need bronchodilator for medical intervention can not beincluded).
  8. Subjects with grade II or higher myocardial ischemia or myocardial infarction, andpoorly controlled arrhythmias (including QTc interval ≥450ms in men and ≥470ms inwomen). According to the New York Heart Association standard, Subjects with gradeIII-IV cardiac insufficiency, or echocardiography showed left ventricular ejectionfraction (LVEF) <50%; myocardial infarction occurred within 6 months beforeenrollment, and New York Heart Association grade II or above cardiac function Failure,uncontrolled angina, uncontrolled severe ventricular arrhythmia, clinicallysignificant pericardial disease, or electrocardiogram suggesting acute ischemia oractive conduction system abnormalities.
  9. Concurrent severe infection (eg, requiring intravenous antibiotics, antifungals, orantivirals) within 4 weeks prior to first dose, or unexplained fever >38.5°C duringscreening or before first dose.
  10. Subjects with a history of psychotropic substance abuse and unable to quit or withmental disorders.
  11. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiencysyndrome (AIDS), active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis Cantibody positive, and HCV-RNA is higher than the detection limit of the analyticalmethod) or co-infection with hepatitis B and C.
  12. Subjects with untreated central nervous system metastases, Subjects who have receivedsystemic, radical brain or meningeal metastases in the past (radiotherapy or surgery),have been stable for at least 1 month if confirmed by imaging, and have stoppedsystemic hormone therapy (Dose > 10mg/day prednisone or other equivalent therapeutichormones) for more than 2 weeks and without clinical symptoms can be included.
  13. Subjects with a history of hereditary or acquired bleeding or coagulation dysfunction (the investigator will determine whether they can be included).
  14. Other conditions not considered suitable for inclusion by the researcher.

Study Design

Total Participants: 92
Study Start date:
March 27, 2022
Estimated Completion Date:
March 27, 2026

Connect with a study center

  • Lei Li

    Beijing, Beijing 100730
    China

    Active - Recruiting

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