Trials / Unknown
UnknownNCT05310383
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
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 58 (estimated)
- Sponsor
- Lei Li · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-03-27
- Primary completion
- 2023-03-27
- Completion
- 2024-03-27
- First posted
- 2022-04-04
- Last updated
- 2022-04-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05310383. Inclusion in this directory is not an endorsement.