RecruitingPhase 2NCT07290010

The Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Esophageal Squamous Cell Carcinoma

A Clinical Trial to Explore the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Recurrent or Metastatic Esophageal Squamous Cell Carcinoma


Sponsor

Hebei Medical University Fourth Hospital

Enrollment

25 participants

Start Date

Sep 26, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-arm clinical trial to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab combined with chemotherapy in the first-line treatment of patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC). After screening and meeting the inclusion criteria, the patients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events, with a total maximum treatment duration of 24 months. The main objective of this study is to: 1. evaluate the ORR of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. 2. The secondary endpoints include PFS, DCR, DoR, OS and safety, etc.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a combination of two immunotherapy drugs (iparomlimab and tuvonralimab) together with chemotherapy can help people with advanced esophageal squamous cell cancer that cannot be surgically removed or has come back after prior treatment. **You may be eligible if...** - You are 18 or older - You have confirmed advanced esophageal squamous cell carcinoma that cannot be cured by surgery - Your cancer recurred more than 6 months after completing adjuvant or radical chemoradiotherapy - You are in good physical condition (ECOG 0–1) - You have at least one measurable tumor - Your heart, lung, liver, and kidney function are within normal range **You may NOT be eligible if...** - Your cancer is a mixed type (adenosquamous or other non-squamous subtype) - You have serious organ dysfunction or other conditions that would prevent safe participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIparomlimab and Tuvonralimab combined with chemotherapy

Patients were enrolled and received 6 cycles of Iparomlimab and Tuvonralimab combined with albumin-bound paclitaxel and cisplatin. Subsequently, maintenance treatment was carried out using Iparomlimab and Tuvonralimab ± albumin-bound paclitaxel until disease progression or the occurrence of unacceptable adverse events 1. Iparomlimab and Tuvonralimab Injection: 5 mg/kg, d1, Q3W; 2. Albumin-bound paclitaxel:100-150 mg/m², d1, d8, Q3W; 3. Cisplatin: 75 mg/m², d1, Q3W;


Locations(1)

Hebei Medical University Fourth Hospital

Shijiazhuang, Hebei, China

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NCT07290010


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