32
Participants
Start Date
January 16, 2023
Primary Completion Date
January 16, 2028
Study Completion Date
December 30, 2028
Chemoradiotherapy + Adjuvant chemotherapy and Zimberelimab
"* Radiation therapy:~ 1\. Irradiation mode and dose: 6MV-X-ray (6Megavoltage-X-ray), IMRT or RapidArc-IMRT were used for external radiotherapy. External radiotherapy dose: PTV (Planning Target Volume) 45-50Gy/25 times.~* Chemotherapy:~ 1. Concurrent chemotherapy: Cisplatin monotherapy: DDP 75 mg/m2 for 3 days, q3w. Carboplatin or nedaplatin may be used in patients that cannot tolerate cisplatin.~ 2. Adjuvant chemotherapy: After the concurrent chemoradiotherapy, 4 cycles of consolidation chemotherapy plus immunotherapy are recommended for patients with high risk or MRDc0 (+). Recommended chemotherapy regimen: liposome paclitaxel 135mg/m2 d1 +DDP 25 mg/m2 D1-3, Q21.~* Zimberelimab injection:~ 240 mg, IV, q3w. Start the drug one day before the start of postoperative radiotherapy."
Chemoradiotherapy (small pelvic) + Zimberelimab
"Radiation therapy:~1\. Target volume of radiotherapy for small pelvis: CTVp includes tumor bed area, paracentral area and part of vagina; CTVn includes bilateral internal iliac, external iliac and obturator lymphatic drainage areas. Upper boundary to sacroiliac joint level, lower boundary to 2cm below vaginal stump.~Chemotherapy:~Concurrent chemotherapy: Cisplatin monotherapy: DDP 75 mg/m2 for 3 days, q3w. Carboplatin or nedaplatin may be used in patients that cannot tolerate cisplatin.~Adjuvant chemotherapy: After the concurrent chemoradiotherapy, 4 cycles of adjuvant immunotherapy are recommended for patients in good general condition (ECOG: 0-1) with medium risk and MRDc0 (-).~Zimberelimab injection: 240 mg, IV, q3w. Start the drug one day before the start of posterior radiotherapy."
RECRUITING
The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou
Suzhou Municipal Hospital
OTHER