Tislelizumab and Radiotherapy for Recurrent Cervical Cancer

Lei Li

Status and phase: Unknown; Phase 2

Conditions: Persistent Cervical Carcinoma; Immune Checkpoint Inhibitors; Survival Outcomes; Immunotherapy; Objective Response Rate; Radiotherapy; Recurrent Cervical Carcinoma; Metastatic Cervical Carcinoma; Tislelizumab; Anti-programmed Cell Death Receptor 1

Treatments: Combination Product: Tislelizumab plus radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05310383

IMURADIO2

Details and patient eligibility

About

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.

Enrollment: 58 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

58 participants in 1 patient group

Patients with recurrent cervical cancer

Experimental group

Description:

Patients with recurrent, metastatic and persistent advanced cervical cancer

Treatment:

Combination Product: Tislelizumab plus radiotherapy