Actively Recruiting

Phase 3
Age: 18Years - 75Years
FEMALE
NCT06459687

Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer

Led by Lee's Pharmaceutical Limited · Updated on 2025-05-14

440

Participants Needed

5

Research Sites

196 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is: Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab. Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6\~8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).

CONDITIONS

Official Title

Phase III Study of Socazolimab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to understand and voluntarily sign written informed consent before study procedures
  • Female aged between 18 and 75 years at time of consent
  • ECOG physical fitness score of 0 or 1
  • Life expectancy of at least 3 months
  • Histologically confirmed cervical cancer not curable by surgery or radiotherapy/concurrent chemoradiotherapy
  • At least one measurable tumor lesion by CT or MRI per RECIST v1.1
  • Provide archived or freshly obtained tumor tissue samples within 5 years prior to randomization
  • Laboratory results show good organ function during screening
  • Use effective contraception from consent signing until 180 days after last study drug administration
Not Eligible

You will not qualify if you...

  • Other histological cervical cancer types such as small cell carcinoma, clear cell carcinoma, sarcoma
  • Prior anti-angiogenic therapy, immune checkpoint inhibitors, or treatments targeting tumor immune mechanisms
  • Active or potentially recurring autoimmune disease
  • Other active malignant tumors within 3 years prior to randomization
  • Participation in other clinical trials with investigational drugs within 4 weeks before randomization
  • Major surgery, open biopsy, or major trauma within 4 weeks before randomization or planned during study
  • Anti-tumor therapy within 4 weeks before randomization
  • Severe infection within 4 weeks prior to randomization
  • Vaccination within 4 weeks prior to randomization
  • Use of immune-modulating drugs within 2 weeks before randomization
  • Use of systemic antibacterial, antiviral, or antifungal drugs within 2 weeks prior to randomization
  • Need for systemic corticosteroids over 10 mg/day prednisone equivalent or other immunosuppressants within 2 weeks prior to randomization
  • Clinically significant hydronephrosis not relieved by nephrostomy or stenting
  • Central nervous system metastases or cancerous meningitis
  • Uncontrolled pleural, pericardial, or peritoneal effusions requiring frequent drainage
  • Known primary or secondary immunodeficiency including HIV positive status
  • History of allogeneic organ or hematopoietic stem cell transplantation
  • Active tuberculosis or active treponema pallidum infection
  • History of severe hypersensitivity to monoclonal antibodies
  • Contraindications or allergies to cisplatin/carboplatin, paclitaxel, or study components
  • Interstitial lung disease, pneumoconiosis, drug-related pneumonia, or severe pulmonary impairment
  • Active viral hepatitis B or C infection or high HBV DNA levels
  • Active or documented inflammatory bowel disease
  • Certain cardiovascular diseases or heart failure NYHA grade II or higher
  • Peripheral neuropathy grade 2 or higher
  • Unrecovered toxicity from prior antitumor therapy
  • Pregnant or lactating women
  • Any condition posing safety risk or interfering with study drug evaluation
  • Contraindications or allergies to bevacizumab or conditions affecting its safe use

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 5 locations

1

Anhui Provincial Cancer Hospital

Hefei, Anhui, China, 230031

Actively Recruiting

2

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China, 100021

Actively Recruiting

3

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430022

Actively Recruiting

4

Hunan Cancer Hospital

Changsha, Hunan, China, 410013

Actively Recruiting

5

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310022

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here