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Trial Title: Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer

NCT ID: NCT05511623

Condition: Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms
Tislelizumab

Conditions: Keywords:
cervical carcinoma
PD-1
chemoradiotherapy

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Patients will be randomized (1:1) to Arm A or Arm B.

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: tislelizumab
Description: standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks, combined with tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year.
Arm group label: tislelizumab

Other name: pd-1 antibody

Intervention type: Other
Intervention name: concurrent chemoradiotherapy
Description: standard radiotherapy with concomitant cisplatin 40mg/m2 on day 1 once every week for 5 weeks.
Arm group label: concurrent chemoradiotherapy

Other name: DDP combined with radiotherapy

Summary: To evaluate the efficacy and safety of tislelizumab combined with concurrent chemoradiotherapy in first-line treatment of stage IIIC2 cervical cancer.

Detailed description: This is a multicenter, prospective, and randomized phase II clinical trial. Patients assigned to experimental group will receive standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks, combined with tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year. Patients assigned to control group will undergo standard radiotherapy with concomitant cisplatin 40mg/m2 once every week for 5 weeks. Compare the efficacy and toxicity of the two regimens in patients with stage IIIC2 cervical cancer.

Criteria for eligibility:
Criteria:
Inclusion criteria: (1)18-70 years old; (2)Histologically confirmed squamous carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix; (3)Patients with 2018 FIGO stage IIIC2 cervical cancer; (4)At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1; (5)Eastern Cooperative Oncology Group score 0-1; (6)No metastatic diseases; (7)Must have an average life expectancy of 6 months; (8)Participants must have normal organ and marrow function as defined below: (hemoglobin ≥90g/L,neutrophils ≥1.5×109/L, platelets ≥80×109/L, ALB≥30g/L, Total bilirubin≤1.5 x institutional upper limit of normal, AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal, Creatinine clearance≥60 mL/min; (9)Patients with menopause, or patients of reproductive potential were required to take effective contraceptive measures for the duration of the study and had a negative pregnancy test result, non-lactating women; (10)Patients volunteered to participate in the study and sign the informed consent. Exclusion criteria: 1. Diagnosed with any other cancer within the past 5 years; 2. Known allergy to any component of the drug; 3. Congenital or acquired immune deficiency (such as HIV infection); 4. The presence of any active, known or suspected autoimmune disease (such as, but not limited to, interstitial pneumonia, uveitis, enteritis, hepatitis, arthritis, nephritis, hypophysitis, hyperthyroidism, hypothyroidism, etc.); Medical history of vitiligo; asthma which requires bronchodilators for medical intervention; 5. Active infection requiring systemic treatment; 6. Previously treatment with PD-1 and/or PD-L1, or CTLA-4 antibody, or other medications targeting immunomodulatory receptors; 7. Patients with grade>2 unrelieved toxic reactions (based on National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] version 5.0) caused by any previous treatment; 8. With a history of myocardial infarction,stroke, unstable angina, decompensated heart failure, or deep vein thrombosis; 9. Long-term uncured wounds or fractures; Major surgery or severe traumatic injury, fracture or ulcer within 4 weeks; 10. Pregnant or lactating women; 11. With metastatic diseases; 12. Liver/renal insufficiency; 13. Those who have a history of psychotropic drug abuse and cannot get rid of it or those with mental disorders; 14. Those who have participated in clinical trials with other drugs within 4 weeks; 15. Patients with concomitant diseases or abnormal test results which interfere with the ability to receive anticancer therapy judged by the investigator; 16. Patients could not gain the maximum benefit from this study judged by the investigator.

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: First Affiliated Hospital of Guangxi Medical University

Address:
City: Nanning
Zip: 530021
Country: China

Status: Recruiting

Start date: September 1, 2022

Completion date: December 31, 2027

Lead sponsor:
Agency: First Affiliated Hospital of Guangxi Medical University
Agency class: Other

Source: First Affiliated Hospital of Guangxi Medical University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05511623

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