Optimization of Postoperative Adjuvant Therapy for Cervical Cancer Based on MRD(Minimal Residual Disease)

PHASE2RecruitingINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

January 16, 2023

Primary Completion Date

January 16, 2028

Study Completion Date

December 30, 2028

Conditions
Cervical Cancer
Interventions
DRUG

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."

DRUG

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."

Trial Locations (1)

215001

RECRUITING

The Affiliated Suzhou Hospital of Nanjing Medical University, Suzhou

All Listed Sponsors
lead

Suzhou Municipal Hospital

OTHER