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

NCT06866951 | Withdrawn Phase 2

• 1 other identifier: PRO2024-777
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 3-year recurrence rate

  From enrollment to the end of treatment at 3 years

Study Arms (2)

Chemo-immunotherapy group

EXPERIMENTAL

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.

Drug: Chemo-immunotherapy

CCRT group

ACTIVE COMPARATOR

Standard treatment includes cisplatin, external beam radiotherapy (EBRT), and brachytherapy. 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.

Radiation: CCRT

Interventions

Chemo-immunotherapy DRUG

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.

Chemo-immunotherapy group

CCRT RADIATION

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.

CCRT group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with cervical squamous cell carcinoma, adenocarcinoma (usual type), or adenosquamous carcinoma who have been pathologically confirmed to have positive retroperitoneal lymph nodes after radical surgery for cervical cancer, i.e., patients with stage IIIC1p and IIIC2p cervical cancer (FIGO 2018);
• Positive expression of PD-L1 in pathological examination, i.e., Combined Positive Score (CPS) ≥1;
• Patients aged ≥18 years and ≤70 years;
• ECOG performance status score ≤1;
• Laboratory tests: White blood cell count (WBC) ≥3.5×10\^9/L, neutrophil count (NEU) ≥1.5×10\^9/L, platelet count (PLT) ≥100×10\^9/L, serum total bilirubin ≤1.5 times the upper limit of normal, serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) ≤1.5 times the upper limit of normal, serum blood urea nitrogen (BUN) ≤1.5 times the upper limit of regular or creatinine clearance rate ≥50 mL/min (creatinine clearance rate can be calculated using the Cockcroft-Gault formula, the Chronic Kidney Disease Epidemiology Collaboration formula, or the Modification of Diet in Renal Disease formula);
• Good compliance of the subjects, who can follow the protocol for efficacy follow-up and adverse events/reactions;
• Subjects voluntarily sign the informed consent form, including adherence to the requirements and restrictions listed in the informed consent form and this protocol.

You may not qualify if:

• Postoperative pathology indicates positive parametrial involvement or positive surgical margins;
• Incomplete radical surgery;
• Postoperative imaging confirms the presence of residual target lesions;
• Any active autoimmune disease or a history of autoimmune disease requiring systemic treatment, including but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, thyroid dysfunction, and asthma requiring intervention with bronchodilators;
• Previous treatment with immune checkpoint inhibitors, including but not limited to other anti-PD-1 and anti-PD-L1 antibodies; known allergy to any component of the study medication or other monoclonal antibodies;
• History of human immunodeficiency virus (HIV) infection, active hepatitis B (HBV-DNA ≥ 2000 IU/mL or 10⁴ copies/mL), or hepatitis C (positive hepatitis C antibody and HCV-RNA above the lower limit of detection of the assay method);
• Receipt of immunosuppressive drugs or systemic corticosteroid therapy for immunosuppressive purposes within 2 weeks before the study drug administration (dose \>10 mg/day of prednisone or equivalent);
• Diagnosis of another primary malignancy within 5 years before the first use of the investigational drug.
• Use any other investigational drug/treatment from another clinical trial within 4 weeks before randomization or concurrent participation in another interventional clinical trial. Participation in observational, non-interventional clinical trials is permitted;
• Pregnant or breastfeeding female patients;
• Uncontrolled concomitant diseases, including but not limited to:
• Cardiovascular diseases: New York Heart Association (NYHA) functional class II or higher, severe/unstable angina, myocardial infarction within ≤6 months before study drug administration, or significant arrhythmias requiring medication or intervention;
• Uncontrolled hypertension;
• Cerebrovascular events or central nervous system disorders within ≤6 months before study drug administration, or patients with abnormal mental status;
• Hematologic disorders: Coagulopathy (INR \> 2.0, PT \> 16 seconds), bleeding tendency, or ongoing thrombolytic or anticoagulant therapy;

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Womens' Hosptial, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2025
• First Posted: March 10, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)