Tislelizumab and Radiotherapy for Recurrent Cervical Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Cervical Carcinoma; Radiotherapy; Immunotherapy; Survival Outcomes; Immune Checkpoint Inhibitors; Objective Response Rate; Metastatic Cervical Carcinoma; Tislelizumab; Persistent Cervical Carcinoma; Anti-programmed Cell Death Receptor 1
• Intervention / Treatment: Combination product: Tislelizumab plus radiotherapy

• Study Type: Interventional
• Enrollment (Anticipated): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Lei Li

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with recurrent cervical cancer; Patients with recurrent, metastatic and persistent advanced cervical cancer	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Overall survival	Overall survival is defined as the duration from date of enrollment to the date of death from any cause	24 months
Adverse Events	Adverse event (AE), Treatment emergent adverse event (TEAE), Serious adverse event (SAE)	24 months

Collaborators and Investigators

• Sponsor: Lei Li

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2022
• Primary Completion (Anticipated): March 27, 2023
• Study Completion (Anticipated): March 27, 2024

Study Registration Dates

• First Submitted: March 26, 2022
• First Submitted That Met QC Criteria: March 26, 2022
• First Posted (Actual): April 4, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Disease Attributes; Carcinoma; Recurrence
• Other Study ID Numbers: IMURADIO2

Drug and device information, study documents

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