Actively Recruiting
The Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Esophageal Squamous Cell Carcinoma
Led by Hebei Medical University Fourth Hospital · Updated on 2025-12-17
25
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Chemotherapy as the First-line Treatment for Esophageal Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with unresectable, recurrent, or advanced metastatic esophageal squamous cell carcinoma confirmed by pathology
- If previously treated with chemotherapy or chemoradiotherapy, at least 6 months have passed since last treatment before recurrence
- ECOG performance status of 0 or 1
- At least one measurable lesion according to RECIST v1.1
- Able to provide tissue samples for PD-L1 testing
- Normal organ function without serious blood, heart, lung, liver, kidney, or immune deficiency issues
- Normal blood clotting with no active bleeding or clotting disorders
- Expected survival time of at least 12 weeks
- Male participants or their female partners of childbearing age must use effective contraception during treatment and for 6 months after
- Willing and able to sign informed consent and comply with study visits and procedures
You will not qualify if you...
- Esophageal cancer that can be cured by surgery or radiotherapy
- Complete esophageal obstruction requiring interventional treatment
- Risk of perforation after esophageal or tracheal stent placement
- Previous systemic treatment for advanced or metastatic esophageal squamous cell carcinoma
- Other cancers diagnosed within 5 years except certain treated skin or cervical cancers and breast cancer in situ
- Severe infections or active lung inflammation
- History of interstitial pneumonia, pneumoconiosis, drug-related pneumonia, or severe lung impairment
- Active tuberculosis infection
- Participation in another interventional clinical trial
- Immune deficiencies including HIV or active hepatitis B or C infections
- History of organ or stem cell transplantation
- Major surgeries within 4 weeks before starting treatment or planned during study
- Symptomatic central nervous system metastases or cancerous meningitis (except stable brain metastases not requiring steroids)
- Active autoimmune diseases needing treatment or recent history within 2 years (with some exceptions)
- Pregnant or breastfeeding females
- Any serious uncontrolled systemic disease increasing participation risk
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, China, 050000
Actively Recruiting
Research Team
S
Shengmian Li
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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