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

Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05511623
• Other study ID #: W2022
• Status: Recruiting
• Phase: Phase 2
• Start date: September 1, 2022
• Est. completion date: December 31, 2027

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital of Guangxi Medical University
• Contact: shanshan ma, M.D.
• Phone: 07715356509
• Email: 56716690[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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:
• concurrent chemoradiotherapy
standard radiotherapy with concomitant cisplatin 40mg/m2 on day 1 once every week for 5 weeks.

Locations

Country	Name	City	State
China	First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Guangxi Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	side effect rate	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0	up to 3 years
Secondary	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
Secondary	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