Actively Recruiting

Phase 3
Age: 18Years - 70Years
All Genders
NCT05357846

PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

Led by Sun Yat-sen University · Updated on 2026-04-30

422

Participants Needed

1

Research Sites

430 weeks

Total Duration

On this page

Sponsors

S

Sun Yat-sen University

Lead Sponsor

A

Affiliated Cancer Hospital of Shantou University Medical College

Collaborating Sponsor

AI-Summary

What this Trial Is About

The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.

CONDITIONS

Official Title

PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0, which is potentially resectable.
  • No prior anticancer therapy received.
  • Expected survival longer than 6 months.
  • Age between 18 and 70 years.
  • Absolute white blood cell count 94.0�d7109/L, neutrophil count 91.5�d7109/L, platelets 9100.0�d7109/L, hemoglobin 90 g/L, and normal liver and kidney function.
  • WHO performance status score of 0 or 1.
  • Signed informed consent document on file.
Not Eligible

You will not qualify if you...

  • Prior anticancer therapy received.
  • Allergy or suspected allergy to sintilimab, toxal, or cisplatin.
  • Presence of hemorrhagic disease.
  • Unable to tolerate surgery.
  • Pregnant or breastfeeding.
  • Lack of informed consent due to psychological, family, social, or other reasons.
  • Concomitant peripheral neuropathy with Common Terminology Criteria (CTC) grade 2 or higher.
  • Malignant tumors other than esophageal cancer, except non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
  • History of diabetes over 10 years with poor glycemic control.
  • Severe heart, lung, liver, renal dysfunction, hematopoietic or immune system diseases, cachexia, or other conditions causing intolerance to chemoradiotherapy or surgery.
  • History of autoimmune diseases, immunodeficiency, or organ/bone marrow transplantation.
  • History of interstitial lung disease or noninfectious pneumonia.
  • Active pulmonary tuberculosis or history within one year before enrollment without regular treatment.
  • Active hepatitis B (HBV DNA 9200 IU/mL) or hepatitis C (HCV antibody positive).

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

Loading map...

Research Team

H

HONG YANG, M.D. Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here