Clinical trial NCT05511623: Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer
Official title: Efficacy and Safety of Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cervical Cancer
Keywords: cervical carcinoma
PD-1
chemoradiotherapy
Lead sponsor: First Affiliated Hospital of Guangxi Medical University
Sponsor class: OTHER
First posted: 2022-08-23
Enrollment: 112
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized (1:1) to Arm A or Arm B.
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: 3-year progress free survival rate
timeFrame: up to 3 years
measure: side effect rate
timeFrame: up to 3 years
Secondary outcomes:
measure: Objective response rate(ORR)
timeFrame: 3 months, after chemoradiotherapy
measure: 3-year overall survival rate
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Nanning
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
Study officials:
affiliation: First Affiliated Hospital of Guangxi Medical University
name: fang wu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: