Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With… (NCT07493993) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Clinical Study on the Efficacy and Safety of Iparomlimab and Tuvonralimab Injection Combined With Nab-Paclitaxel in Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
China26 participantsStarted 2026-06-01
Plain-language summary
Major objectives to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706,an Anti-PD-1/CTLA-4 Combined Antibody) combined with Nab-Paclitaxel in neoadjuvant therapy for patients with locally advanced resectable esophageal squamous cell carcinoma.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Voluntarily understand and sign the informed consent form for this study.
* Age ≥ 18 years, male or female.
* Histologically or cytologically confirmed thoracic ESCC (Stage T1-2N1-2M0 or T3N0-2M0, according to the AJCC 8th edition).
* ECOG performance status of 0-2.
* No prior treatment for esophageal squamous cell carcinoma.
* Life expectancy ≥ 3 months.
* Adequate function of major organs within 7 days before the first treatment (use of any blood components or cell growth factors within 14 days before enrollment is not permitted):Hemoglobin ≥ 90 g/L; White blood cell count ≥ 3.5 × 10\^9/L; Absolute neutrophil count ≥ 1.5 × 10\^9/L; Platelets ≥ 80 × 10\^9/L; AST and ALT ≤ 2.5 × ULN; Total bilirubin (TBIL) ≤ 1.5 × ULN; Blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN (and creatinine clearance (CCr) ≥ 50 mL/min); Left ventricular ejection fraction (LVEF) ≥ 50%.
* Fertile patients must agree to use reliable contraceptive methods with their partner during the trial and for at least 180 days after the last dose.
Exclusion Criteria:
* Inability to comply with the study protocol or study procedures.
* Presence of supraclavicular lymph node metastasis.
* Obvious tumor invasion of organs adjacent to the esophageal lesion.
* Evidence of esophagomediastinal or tracheoesophageal fistula found on imaging within 4 weeks before enrollment.
* Allergy or known hypersensitivity to the study drugs or their excipients.
* Anticipated need for systemic corticoste…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathologic complete response rate (pCR)
Timeframe: up to 6 month
Trial details
NCT IDNCT07493993
SponsorTianjin Medical University Cancer Institute and Hospital