Tislelizumab and Radiotherapy for Recurrent Cervical Cancer

Immunotherapy Clinical Trial

Official title:

Combination of Immune Checkpoint Inhibitors Tislelizumab and Radiotherapy for Recurrent, Metastatic and Persistent Advanced Cervical Cancer: A Single-arm, Single-center, Phase 2 Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05310383
• Other study ID #: IMURADIO2
• Status: Recruiting
• Phase: Phase 2
• Start date: March 27, 2022
• Est. completion date: March 27, 2024

Study information

• Verified date: April 2022
• Source: Peking Union Medical College Hospital
• Contact: Lei Li, M.D.
• Phone: 86-139-1198-8831
• Email: lileigh[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a prospective, multicenter, phase II clinical trial to evaluate the efficacy and safety of albumin-bound paclitaxel plus bevacizumab for platinum-resistant recurrent epithelial ovarian cancer. Patients with platinum-resistant recurrent ovarian cancer who meet the inclusion criteria, and don't meet any of the exclusion criteria, are enrolled in the study. They will receive albumin-bound paclitaxel (260 mg/m2) and bevacizumab (7.5mg/kg) intravenously every 21 days. The total treatment periods are no more than 6 cycles. Treatment continue until disease progression, intolerable toxicity, or patient refusal. Objective response rates primary objective. Progression-free survival, overall survival, and safety are secondary objectives. The study will enroll a total of 50 patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 58
• Est. completion date: March 27, 2024
• Est. primary completion date: March 27, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. The patient voluntarily participates and signs informed consent

2. Aged 18 years of age or older

3. Has an Eastern Cooperative Oncology Group (ECOG) performance status = 2 within 7 days prior to the first dose of study treatment

4. Has recurrent cervical cancer and controllable local treatment, indicating an indication for radiation therapy

5. Willing to accept concurrent radiotherapy combined with Tislelizumab

6. Has measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the local investigator

7. Has adequate organ function

8. Has expected survival time =3 months

Exclusion Criteria:

1. Has received prior therapy with an anti-programmed cell death receptor 1 (PD-1), or with an agent directed to another stimulatory or co-inhibitory T-cell receptor

2. Has a known history of Human Immunodeficiency Virus (HIV) infection,active Hepatitis virus infection and active tuberculosis (TB; Bacillus tuberculosis)

3. Has known active central nervous system (CNS) metastases and/or uncontrolled, untreated carcinomatous meningitis with elevated intracranial pressure

4. Has received a major surgery within 4 weeks prior to signing informed consent

5. Not suitable for radiotherapy

6. Reassessment of liver and kidney function and blood routine indexes after radiotherapy did not meet the above criteria

7. Did not meet the other requirements for inclusion by the investigator

8. Judged unqualified of the enrollment requirements by the researcher according to other conditions

Related Conditions & MeSH terms

• Carcinoma
• Immune Checkpoint Inhibitors
• Immunotherapy
• Metastatic Cervical Carcinoma
• Objective Response Rate
• Radiotherapy
• Recurrent Cervical Carcinoma
• Survival Outcomes
• Uterine Cervical Neoplasms

Intervention

Combination Product:
• Tislelizumab plus radiotherapy
During the period of radiotherapy, patients receiveTislelizumab 200 mg intravenously (IV) on Day 1 of each 3-week cycle (Q3W). Tislelizumab 200mg q3W was administered for up to 35 cycles (up to approximately 2 years) after radiotherapy until disease progression or toxicity.

Locations

Country	Name	City	State
China	Lei Li	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lei Li

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate	Overall survival is defined as the duration from date of enrollment to the date of death from any cause	12 months
Secondary	Progression-free survival (PFS)	PFS defined as the time the duration from date of enrollment to the first documented disease progression, or death due to any cause, whichever occurs first.	12 months
Secondary	Overall survival	Overall survival is defined as the duration from date of enrollment to the date of death from any cause	24 months
Secondary	Adverse Events	Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)	24 months