Zimberelimab Combined With Concurrent Radiotherapy and Chemotherapy for Locally Advanced Cervical Cancer
NCT05437692 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2022-10-12
Summary
This is a prospective, single arm, phase II clinical study on the treatment of locally advanced cervical cancer (Ⅱ B to Ⅳ a) with Zimberelimab combined with concurrent radiotherapy and chemotherapy.
Conditions
- Locally Advanced Cervical Cancer
Interventions
- DRUG
-
zimberelimab combined With concurrent radiotherapy and chemotherapy
zimberelimab: 240 mg Q2W Intravenous drip,The maximum duration of medication shall not exceed one years; chemotherapy: Starting from the first week of radiotherapy and chemotherapy, cisplatin 40mg/m2 and paclitaxel 35mg/m2 were given intravenously for 30-60min; Radiotherapy: intensity modulated radiation therapy (IMRT) was used for external irradiation. The total dose of pelvic cavity and lymph drainage planning target area (PTV) was 45-50 gy/25-28f. The metastatic lymph nodes should be able to supplement or synchronously push 10-15 Gy; The internal irradiation was started within 2 weeks after the end of external irradiation treatment. The image-guided three-dimensional brachytherapy was used, and 30-40gy was added to make the total dose of point a reach 80-85 Gy, twice a week, 5-6gy each time. All radiotherapy was completed within 8 weeks.
Sponsors & Collaborators
-
Shanghai Zhongshan Hospital
lead OTHER
Principal Investigators
-
Lin Genlai, MD · Shanghai Zhongshan Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-07-15
- Primary Completion
- 2024-07-01
- Completion
- 2025-07-01
Countries
- China
Study Locations
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