Clinical trial NCT05310383: Tislelizumab and Radiotherapy for Recurrent Cervical Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Cervical Carcinoma
Metastatic Cervical Carcinoma
Persistent Cervical Carcinoma
Radiotherapy
Immunotherapy
Anti-programmed Cell Death Receptor 1
Immune Checkpoint Inhibitors
Tislelizumab
Objective Response Rate
Survival Outcomes
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-04-04
Enrollment: 58
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Objective Response Rate
timeFrame: 12 months
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: 12 months
measure: Overall survival
timeFrame: 24 months
measure: Adverse Events
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References: