Starting chemo plus PD-1 immunotherapy before radiation versus giving chemo during radiation for unresectable locally advanced esophageal squamous cell carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized phase II trial that will assign eligible patients with unresectable stage III-IVA esophageal squamous cell carcinoma 1:1 to two treatment strategies. The experimental arm receives three cycles of induction chemo-immunotherapy (chemotherapy plus a PD-1 antibody), then definitive thoracic radiotherapy and up to one year of PD-1 antibody maintenance; the control arm receives concurrent chemo-radiotherapy followed by the same maintenance. The co-primary endpoints are complete response rate at 3 months after radiotherapy and 1-year progression-free survival, with secondary endpoints including overall survival, objective response rate, recurrence-free measures, quality of life, and safety. The trial aims to determine whether sequencing immunotherapy before radiotherapy can improve local control and longer-term outcomes compared with the current concurrent approach.

Why it matters

Who can join: the full rules

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

Where it's running

• The Second Affiliated Hospital of Zunyi Medical University, Xinpu New District, Honghuagang District, Zunyi City, Guizhou Province
  Zunyi, Guizhou, China Recruiting

Study contacts

• Principal investigator: Lei Zhou, Master — The Second Affiliated Hospital of Zunyi Medical University
• Study coordinator: Jian-Guo Zhou, PhD
• Email: jsdxzl@126.com
• Phone: +86-851-18212154044

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.