|

Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

RECRUITINGPhase 2Sponsored by Second Affiliated Hospital of Zunyi Medical University
Actively Recruiting
PhasePhase 2
SponsorSecond Affiliated Hospital of Zunyi Medical University
Started2026-01-01
Est. completion2028-01-01
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07559045

Summary

This is a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC). Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups. The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy. The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy. The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate. Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
Inclusion Criteria:

* Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC)
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate organ function (bone marrow, liver, renal, cardiac) within 2 weeks prior to randomization
* Measurable or evaluable disease per RECIST 1.1
* Willing to provide written informed consent

Exclusion Criteria:

* Previous radiotherapy to the chest or previous systemic chemotherapy for ESCC
* History of other malignancies within the last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)
* Severe comorbidities (uncontrolled hypertension, NYHA class III-IV heart failure, active infection, etc.)
* Known hypersensitivity to any study drugs (paclitaxel, cisplatin/carboplatin, PD-1 antibody)
* Pregnant or lactating women
* Participation in another clinical trial within 30 days prior to randomization

Conditions2

CancerEsophageal Squamous Cell Carcinoma (ESCC)

Browse More Trials

Cancer trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.