Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter Clinical Trial

NCT07332221 | Not Yet Recruiting Phase 3

• 1 other identifier: 2025-586
• Study Type: interventional
• Target: 435
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a prospective, multicenter, multi-cohort Phase III clinical trial. It primarily enrolls high-risk recurrent esophageal cancer patients who have undergone R0 resection after neoadjuvant chemoimmunotherapy. Eligible patients are stratified based on pathological lymph node status and receive either toripalimab monotherapy as maintenance treatment or clinical observation only.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 2-year OS

  the percentage of patients in a study who are still alive after 2years

  every 3 months for 2 years

Secondary Outcomes (2)

• DFS

  every 6 months until the 5th year

• OS

  every 6 months until the 5th year

Study Arms (3)

ypN+，receive toripalimab monotherapy as maintenance treatment

EXPERIMENTAL

R0 resection for esophageal cancer, ypN+

Drug: Toripalimab monotherapy

ypN-，receive toripalimab monotherapy as maintenance treatment

EXPERIMENTAL

R0 resection for esophageal cancer, ypN-，receive toripalimab monotherapy as maintenance treatment

Drug: Toripalimab monotherapy

ypN-，clinical observation only

NO INTERVENTION

R0 resection for esophageal cancer, ypN-，no further treatment

Interventions

Toripalimab monotherapy DRUG

Toripalimab monotherapy as maintenance treatment

ypN+，receive toripalimab monotherapy as maintenance treatment; ypN-，receive toripalimab monotherapy as maintenance treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up.
• Initial patients are those with resectable or potentially resectable (T1 N1-3 M0 or T2-3 N0-3 M0) thoracic segment esophageal squamous cell carcinoma (8th UICC-TNM staging); who have undergone surgical resection after 2 cycles of immunotherapy combined with chemotherapy and achieved R0 resection.
• Age 18 to 75 years.
• Preoperative examinations of various organ functions indicate no surgical contraindications.
• The following laboratory tests confirm that bone marrow, liver, and kidney functions meet the study requirements:
• Hemoglobin ≥ 90 g/L; White blood cell count ≥ 4.0 × 10⁹/L; Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); ALT and AST ≤ 2.5 times ULN; International normalized ratio (INR) of prothrombin time ≤ 1.5 times ULN, and activated partial thromboplastin time within the normal range; Creatinine ≤ 1.5 times ULN.
• No postoperative chemotherapy, radiotherapy, or hormone therapy for malignant tumors has been administered; no history of other malignancies, excluding prostate cancer patients who have received hormone therapy and achieved disease-free survival (DFS) for over 5 years.
• Physical status ECOG score 0 to 1.
• Women of childbearing potential must agree to use contraceptive measures (e.g., intrauterine device, contraceptive pills, or condoms) during the study and for 6 months after study completion; serum or urine pregnancy test within 7 days before study enrollment must be negative, and patients must be non-lactating; men must agree to use contraceptive measures during the study and for 6 months after study completion.

You may not qualify if:

• Patients with double primary cancers;
• Patients with infections requiring treatment;
• Patients requiring continuous systemic corticosteroid therapy (Note: Replacement therapy (e.g., for thyroid insufficiency, insulin therapy, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered systemic therapy and is permitted);
• Patients with unstable angina within 3 months or myocardial infarction within 6 months;
• Patients with psychiatric disorders;
• Patients with existing or concurrent hemorrhagic disorders;
• Female patients who are pregnant or breastfeeding;
• Patients with bronchial asthma requiring intermittent use of bronchodilators or medical intervention;
• Patients who have used immunosuppressive agents prior to enrollment due to comorbid conditions, with a dose equivalent to ≥10mg/day of oral prednisone sustained for more than 2 weeks;
• Patients with abnormal coagulation function (PT \> 16s, APTT \> 53s, TT \> 21s, Fib \< 1.5g/L), bleeding tendency, or those receiving thrombolytic or anticoagulant therapy;
• Patients with pre-existing or concurrent pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, severe pulmonary impairment, etc.;
• Patients with autoimmune diseases, immunodeficiency, or organ transplantation;
• Patients with active Hepatitis B or Hepatitis C infection.

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Yan Zheng, M.D.

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Zheng, M.D.

CONTACT

0371-65587610; hnszlyylixiang@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Trials Center

Study Record Dates

• First Submitted: December 29, 2025
• First Posted: January 12, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2031
• Last Updated: January 12, 2026

Record last verified: 2026-01