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

Efficacy and Safety of Tislelizumab Combined With Concurrent Chemoradiotherapy as First-line Treatment for Stage IIIC2 Cervical Cancer

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

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Drug: tislelizumab; Other: concurrent chemoradiotherapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: shanshan ma, M.D.; Phone Number: 07715356509; Email: 56716690@qq.com
• Study Contact Backup: Name: yong zhang, M.D.; Phone Number: 07715356509; Email: zhangyonggx@163.com

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Recruiting
      • First Affiliated Hospital of Guangxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tislelizumab; 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.	Drug: tislelizumab; 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.; Other Names: pd-1 antibody
Active Comparator: concurrent chemoradiotherapy; 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.	Other: concurrent chemoradiotherapy; standard radiotherapy with concomitant cisplatin 40mg/m2 on day 1 once every week for 5 weeks.; Other Names: DDP combined with radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year progress free survival rate	Progression-free survival (PFS) is defined as the time between entry into the study and progression of the tumor (in any respect) or death (from any cause).	up to 3 years
side effect rate	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate(ORR)	ORR is defined as the proportion of patients with CR or PR, assessed by RECIST v1.1 per independent central radiologic review.	3 months, after chemoradiotherapy
3-year overall survival rate	overall survival rate（OS）is calculated from the date of entry into the study to the date of death or the last follow-up visit.	up to 3 years

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Guangxi Medical University
• Investigators: Principal Investigator: fang wu, M.D., First Affiliated Hospital of Guangxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 23, 2022

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 8, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: cervical carcinoma; PD-1; chemoradiotherapy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Uterine Cervical Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Tislelizumab
• Other Study ID Numbers: W2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No