A Clinical Study Comparing Chemotherapy Combined With PD-1 Inhibitor Versus Concurrent Chemoradiotherapy in Cervical Cancer Patients With Positive Lymph Nodes After Surgery: A Multicenter Randomized Controlled Clinical Trial

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

440

Participants

Timeline

Start Date

March 1, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2030

Conditions
Cervical Cancers
Interventions
DRUG

Chemo-immunotherapy

"Post-radical surgery for cervical cancer, the first cycle of PD-1 inhibitor combined with chemotherapy will begin 2 to 3 weeks after surgery. Each treatment cycle lasts 21 days, with a total of 6 cycles. A complete imaging efficacy evaluation will be conducted after every 3 treatment cycles. For patients with lymph node metastasis ≥3 or para-aortic lymph node metastasis, 6 cycles of chemotherapy combined with immunotherapy will be administered. Other patients will receive 3 cycles of chemotherapy combined with immunotherapy.~Treatment regimen:~Day 1:~Paclitaxel (albumin-bound) for injection: 260 mg/m², administered intravenously over 30 minutes.~Day 1 to Day 2:~Cisplatin 75-80 mg/m², administered intravenously at a 1 mg/min rate.~Day 3:~PD-1 inhibitor (Camrelizumab for injection, Aikening): 200 mg per dose, infused over 30 to 60 minutes."

RADIATION

CCRT

"The overall chemoradiotherapy (including EBRT and brachytherapy) should typically be completed within 6 weeks (with a maximum extension to 10 weeks in case of anticipated delays). External beam radiotherapy (EBRT) should be at least three-dimensional conformal radiotherapy, with image-guided (CT or MR) intensity-modulated conformal radiotherapy techniques recommended, at a 45-50 Gy dose.~Concurrent Chemotherapy:~Cisplatin (40 mg/m²) is preferred on a weekly schedule (administered before the planned EBRT on the same day, once a week \[±1-day window\], for a total of 5-6 infusions). Carboplatin can be used as an alternative if cisplatin toxicity is not tolerated."

Trial Locations (1)

310000

Womens' Hosptial, School of Medicine, Zhejiang University, Hangzhou

All Listed Sponsors
lead

Women's Hospital School Of Medicine Zhejiang University

OTHER

NCT06866951 - A Clinical Study Comparing Chemotherapy Combined With PD-1 Inhibitor Versus Concurrent Chemoradiotherapy in Cervical Cancer Patients With Positive Lymph Nodes After Surgery: A Multicenter Randomized Controlled Clinical Trial | Biotech Hunter | Biotech Hunter