Actively Recruiting

Phase 2
Age: 18Years - 75Years
FEMALE
NCT06942416

Iparomlimab and Tuvonralimab With Chemoradiation for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer

Led by Shandong Cancer Hospital and Institute · Updated on 2025-04-24

36

Participants Needed

1

Research Sites

200 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The goal of this clinical trial is to evaluation the efficacy and safety of iparomlimab and tuvonralimab, paclitaxel + cisplatin/carboplatin combined with radiotherapy of locally recurrent and oligometastatic cervical cancer.The main questions it aims to answer are: 1. Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants? 2. What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy? Participants will: * Receive iparomlimab and tuvonralimab, Paclitaxel + Cisplatin/Carboplatin and radiation therapy according to a specified protocol. * Visit the clinic for regular checkups and tests throughout the treatment period. * Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety. * Provide hematologic、tissue and stool samples to explore biomarkers. This study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic cervical cancer as well as identify biomarkers to better guide treatment strategies.

CONDITIONS

Official Title

Iparomlimab and Tuvonralimab With Chemoradiation for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer

Who Can Participate

Age: 18Years - 75Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed written informed consent before any trial procedures
  • Female aged 18 to 75 years
  • ECOG performance status 0-1
  • Confirmed diagnosis of cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma)
  • Locally recurrent or oligometastatic cervical cancer with 5 or fewer total lesions
  • At least one measurable lesion suitable for radiotherapy
  • Available tumor tissue for biomarker testing
  • Expected survival of 6 months or more
  • Normal organ function within 7 days before enrollment including blood counts and liver/kidney tests
  • Prior anti-tumor treatment toxicities recovered to Grade 1 or less except specified exceptions
  • Use of effective contraception during treatment and 3 months after if not sterilized or postmenopausal
  • Negative pregnancy test within 7 days before enrollment
  • Expected to comply with study follow-up
Not Eligible

You will not qualify if you...

  • Prior immunotherapy or gastric-type adenocarcinoma diagnosis
  • Active or history of autoimmune disease except certain controlled conditions
  • Use of immunosuppressants or corticosteroids within 2 weeks before enrollment
  • History of severe immune-related adverse events from prior immunotherapy
  • Poorly controlled heart conditions including recent heart attack or severe arrhythmias
  • Abnormal blood clotting or current anticoagulant use
  • Recent prior cancer treatments within specified washout periods
  • Uncontrolled fluid buildup requiring drainage
  • Significant recent hemoptysis
  • Known bleeding or clotting disorders
  • Active infection or fever above 38.5°C before treatment
  • Severe lung diseases or dysfunction
  • Immunodeficiency or active hepatitis beyond specified limits
  • Use of other investigational drugs recently
  • Concurrent or prior cancers except certain cured skin or cervical cancers
  • Planned systemic anti-tumor therapy during study
  • Recent or planned live vaccinations
  • Other serious medical, psychiatric, or social conditions that affect safety or study completion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shandong Cancer Hospital Affiliated to Shandong First Medical University

Jinan, Shandong Recruiting, China

Actively Recruiting

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Research Team

J

Jing liu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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