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

NCT06942416 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2025-04-24

No results posted yet for this study

Summary

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

Interventions

DRUG

Paclitaxel and Cisplatin/ Carboplatin

Paclitaxel and Cisplatin Paclitaxel: 135 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W). Cisplatin: 75 mg/m², intravenous infusion, Days 1-3, every 3 weeks (Q3W). Carboplatin 0.3-0.4g/m², intravenous infusion, Day 1, Q3W .Duration: 4-6 cycles.

DRUG

Iparomlimab and Tuvonralimab

Iparomlimab and Tuvonralimab 5mg/kg, intravenous infusion, Day 1, Q3W. Duration: Continuous administration until disease progression, death, intolerable toxicity, subject's voluntary withdrawal, investigator's decision for withdrawal, or a maximum of 24 months.

RADIATION

Radiotherapy

Site Selection: Original site, lymph nodes, lung metastasis, bone metastasis, adrenal metastasis, brain metastasis, and other relatively isolated, well-vascularized lesions. Select at least one suitable lesion for radiotherapy based on the impact of the recurrent or metastatic lesion on the body, prioritizing lesions that cause symptoms, are life-threatening, or are expected to cause symptoms.All tumor lesions will be irradiated, which can be done in phases. Dosage and Fractionation: Conventional or hypofractionated radiotherapy, with a biologically effective dose (BED) of ≥ 72 Gy. Dose adjustments can be made for brain metastases. Timing: After completing relevant baseline examinations, radiotherapy can be implemented generally after 4-6 cycles of systemic therapy, or after the first cycle for small, solitary metastatic lesions. echnique: IMRT, TOMO, SBRT, 3D-BT, interstitial implantation therapy, or proton therapy.

Sponsors & Collaborators

  • Shandong Cancer Hospital and Institute

    lead OTHER

Principal Investigators

  • Peng Xie · Shandong Cancer Hospital and Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-28
Primary Completion
2026-07-31
Completion
2028-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06942416 on ClinicalTrials.gov