MedTrace Logo

A Phase II Study of Toripalimab Plus Chemotherapy and Low-Dose Radiotherapy for Neoadjuvant Therapy-Refractory Esophageal Squamous Cell Carcinoma

NCT07272291 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-09

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant toripalimab combined with chemotherapy and low-dose radiotherapy in patients with esophageal squamous cell carcinoma who are insensitive to neoadjuvant therapy. The main question it aims to answer is:

• Whether adding low dose radiotherapy can improve the efficacy of immunotherapy combined chemotherapy in neoadjuvant setting?

Participants will receive low-dose radiotherapy (1.2 Gy/fraction, 5 fractions), followed by 2 cycles of chemotherapy plus toripalimab (240 mg, q3w). 6 to 8 weeks after treatment completion, a systematic preoperative assessment is conducted, then surgery is performed. Postoperatively, management depends on pathological results:

Non-pathological complete response (non-pCR) patients: Toripalimab monotherapy continues until disease recurrence, intolerable toxicity, informed consent withdrawal, or for 1 year (whichever comes first).

Pathological complete response (pCR) patients: Directly undergo regular postoperative survival follow-up

Conditions

  • Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

DRUG

Toripalimab

After 2 cycles of neoadjuvant therapy with stable disease (SD) in efficacy assessment, subjects will sign the informed consent form. Baseline assessment is conducted within 4 weeks before enrollment. Enrolled patients first receive low-dose radiotherapy (1.2 Gy × 5), then continue with 2 cycles of the chemotherapy regimen combined with toripalimab (240 mg, once every 3 weeks), followed by surgical treatment. Subsequently, based on pathological results: Non-pCR patients receive toripalimab monotherapy until disease recurrence, intolerable toxicity, or subject's withdrawal of informed consent. The total duration of study drug administration is at most 1 year, whichever comes first. pCR patients directly undergo regular post-surgical survival follow-up.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-25
Primary Completion
2027-12-25
Completion
2028-12-25

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07272291 on ClinicalTrials.gov