Sintilimab for non-pathologic complete response (non-pCR) esophageal squamous cell carcinoma after neoadjuvant chemoradiotherapy and surgery: a multicentre, randomised, phase 2 trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2200060318

Enrollment

Unknown

Registered

2022-05-28

Start date

2022-05-15

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

esophageal squamous cell carcinoma

Interventions

Group 1 :Sintilimab

Group 2:observation

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old, fully understand the content and risks of this clinical trial, and sign the informed consent; 2. Patients with operable esophageal squamous cell carcinoma who do not have pCR after neoadjuvant radiotherapy and chemotherapy; 3. Paraffin specimens or pathological sections before and after neoadjuvant therapy can be obtained; 4. The ECOG score is 0 or 1, and the expected survival time is more than 3 months; 5. The patients had no obvious bone marrow suppression at the time of enrollment: hemoglobin >= 9 g/dl, neutrophils >= 1.5 x 10^9/L, platelets >= 100 x 10^12/L.

Exclusion criteria

Exclusion criteria: 1. Breastfeeding or pregnant women; 2. Patients with grade >= 3 radiation pneumonitis during neoadjuvant chemotherapy before enrollment; 3. Patients with severe heart, lung, liver, kidney dysfunction, hematopoietic system disease, immune system disease, cachexia, etc. cannot tolerate immune consolidation therapy; 4. Active infection, active tuberculosis infection, active tuberculosis infection in the past, hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), acquired immunodeficiency syndrome antibody (Anti-HIV) and anti-Treponema pallidum Antibody (TP-Ab) positive, who meet any one of them; 5. Patients with other tumors within 5 years; 6. Other conditions that the researchers think are not suitable for enrollment.

Design outcomes

Primary

Measure	Time frame
disease free survival;	—

Secondary

Measure	Time frame
overall survival;treatment-related adverse events;	—

Countries

China

Contacts

Public ContactBaosheng Li

Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences

bsli@sdfmu.edu.cn+86 531 67626161

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026