Comparing immunochemotherapy and chemotherapy for esophageal cancer before surgery

A Phase III, Randomized Controlled Study of Neo-adjuvant Toripalimab (JS001) in Combination With Chemotherapy Versus Neo-adjuvant Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma

This study is testing if a new combination of immunotherapy and chemotherapy can help people with esophageal cancer live longer and have better outcomes before surgery compared to standard chemotherapy.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: radiation, Toripalimab, chemotherapy, immunotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT04280822 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of neo-adjuvant immunochemotherapy using Toripalimab combined with cisplatin and paclitaxel in improving survival rates for patients with resectable thoracic esophageal squamous cell carcinoma. The study aims to determine if this approach offers better outcomes compared to standard neo-adjuvant chemotherapy. Participants will undergo treatment followed by surgical resection and lymph node dissection. The trial is designed as a Phase III study to provide robust evidence on the potential benefits of immunotherapy in this context.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced thoracic esophageal squamous cell carcinoma who have not received prior anticancer therapy.

Not a fit: Patients with metastatic disease or those who have received prior treatment for esophageal cancer are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for patients with esophageal cancer.

How similar studies have performed: Previous studies have shown promising results for immunotherapy in treating esophageal cancer, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Histologic diagnosis of local advance squamous cell thoracic esophageal carcinoma of Stage (T1N1-3 or T2-3N0-3 M0), (8th Union for International Cancer Control, UICC-TNM).
2. No metastatic lymph node in cervical by color doppler sonography.
3. Patients must not have received any prior anticancer therapy of esophageal carcinoma.
4. Age ranges from 18 to 75 years.
5. Without operative contraindication.
6. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney, total bilirubin（TBIL）≤1.5N, aspartate aminotransferase (AST)≤2.5N, alanine aminotransferase(ALT)≤2.5N, prothrombin time(PT)≤1.5N, and activated partial thromboplastin time(APTT) is in normal range, endogenous creatinine clearance rate(CRE)≤1.5N.
7. Patients must not have diagnosed with other cancer and must not received any prior anticancer therapy except prostatic cancer with more than 5 years disease-free survival(DFS).
8. expected R0 resection.
9. ECOG 0～1.
10. Patients should agree to use contraceptive measures during the study period and within 6 months of the end of the study. Women must be non-lactation.
11. Signed informed consent document on file. 10. .

Exclusion Criteria:

* 1\. Multiple primary cancer. 2.Patients with infections disease that require treatment 3.Patients who need continuous hormone treatment 4.unstable angina within 3 months, myocardial infarction within 6 months 5.psychopath 6.Patients with concomitant hemorrhagic disease. 7.Any unexpected reason for patients can't get operation 8.Inability to use gastric conduit after esophagectomy because of a prior surgery.

  9.Pregnant or breast feeding 10.Patients are diagnosed or suspected to be allergic to cisplatin or Paclitaxel.

  11.Bronchial asthma who requires intermittent use of bronchodilators or medical interventions 12.Due to co-existing diseases, the immunosuppressant was used. And the dosage of immunosuppressant was more than 10mg/ day orally and more than 2 weeks before enrollment 13.Abnormal coagulation function (PT\>16s, APTT\>53s, TT\>21s, Fib\<1.5g/L), tendency of bleeding or receiving thrombolysis or anticoagulant therapy 14.Previous or present pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, lung function severely impaired 15.Autoimmune diseases, immune deficiency, organ transplantation； 16.Hepatitis b/c patients。

Where this trial is running

Zhengzhou, Henan

• Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University) — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Yan Zheng, PhD, MD — Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
• Study coordinator: Yan Zheng, PhD, MD

Conditions Esophageal Cancer; Surgery; Neoadjuvant Treatment; Survival; Neoadjuvant chemotherapy; Neoadjuvant immunochemotherapy