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

Summary

This study aims to conduct a prospective, multicenter, randomized controlled trial targeting patients with cervical cancer who have been pathologically confirmed to have lymph node metastasis after surgery. The study will proceed as follows:

Patients who have undergone cervical cancer surgery and have been pathologically confirmed to have positive retroperitoneal lymph nodes will be selected according to the inclusion and exclusion criteria. Their clinical and pathological data will be collected. These patients will be randomly assigned in a 1:1 ratio to two groups: the chemotherapy-immunotherapy (chemo-immunotherapy) group and the concurrent chemoradiotherapy group.

The study will compare the two treatment strategies by evaluating tumors' 3-year recurrence rate, distant metastasis rate, and overall survival prognosis in patients. The primary endpoints are the 3-year recurrence rate and distant metastasis rate. Secondary endpoints include the 3-year local recurrence rate, progression-free survival (PFS), and overall survival (OS). Additionally, the study will assess differences in complications, toxic side effects of chemotherapy and radiotherapy, and quality of life between the two groups to determine the value of chemo-immunotherapy in treating this patient population.

In addition, biological tissue samples from 50 patients in the chemo-immunotherapy cohort will be collected for multi-omics analysis and detection of immune-related biomarkers. Using bioinformatics methods, the study will analyze the differences in cellular immune subtypes and immune-related biomarkers between patients who benefit from the treatment and those who do not. This analysis aims to clarify the therapeutic efficacy of chemo-immunotherapy in patients with postoperative lymph node metastasis after cervical cancer surgery and to identify biomarkers and immune markers associated with treatment benefits.

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.

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-01

Primary Completion

2028-12-31

Completion

2030-12-31

Countries

• China

Study Locations