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

F

First Affiliated Hospital of Guangxi Medical University

Status and phase

Enrolling
Phase 2

Conditions

Cervical Cancer

Treatments

Drug: tislelizumab
Other: concurrent chemoradiotherapy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

112 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

112 participants in 2 patient groups

tislelizumab
Experimental group
Description:
The external radiation is administered at 45-50Gy/25f and brachytherapy is performed sequentially at 6Gy/time to a total doses of 30 Gy. The concomitant chemotherapy regimen is cisplatin 40mg/m2 on day 1 once every week for 5 weeks. In addition, patients also receive tislelizumab (200 mg, day 1) once every 3 weeks until disease progression or intolerable toxicity occurs or one year.
Treatment:
Drug: tislelizumab
concurrent chemoradiotherapy
Active Comparator group
Description:
The external radiation is administered at 45-50Gy/25f and brachytherapy is performed sequentially at 6Gy/time to a total doses of 30 Gy. The concomitant chemotherapy regimen is cisplatin 40mg/m2 on day 1 once every week for 5 weeks.
Treatment:
Other: concurrent chemoradiotherapy

Trial contacts and locations

1

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Central trial contact

shanshan ma, M.D.; yong zhang, M.D.

Data sourced from clinicaltrials.gov

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