Immunotherapy Plus Chemotherapy vs. Chemoradiotherapy for Thoracic Squamous Esophageal Carcinoma

• Status: Not yet recruiting
• Trial end date: 2026-05-30
• Target enrollment: 0
• Participant gender: All

Summary

The investigators conducted a phase II, prospective, two-arm clinical study to explore the efficacy of Camrelizumab combined with chemotherapy versus chemoradiotherapy for conversion therapy of potentially resectable advanced esophageal squamous cell carcinoma. This study will provide more evidence for conversion treatment of initially unresectable locally advanced esophageal squamous cell carcinoma and contribute to the development of treatment guidelines for esophageal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Medical University Union Hospital
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• histologically-confirmed squamous cell carcinoma

• primary lesions located in the thoracic esophagus

• clinical stage cT4 or at least one group of lymph nodes invade the surrounding organs and unresectable lymph nodes

• having not received neoadjuvant therapy

• 18-75 years

• ECOG performance status of 0 or 1

• no prior chemotherapy, radiotherapy, or immunotherapy for any cancers

• adequate organ function

• expectation of R0 resection

• provision of written informed consent.

Exclusion Criteria:

• corticosteroid treatment (equivalent to prednisone >10 mg/day) within 14 days before the first day of the drug administration

• acquired immunodeficiency syndrome or active hepatitis B (DNA ≥ 104 copies/ml) or C (RNA ≥ 103 copies/ml) viral infections

• history of pneumonitis or interstitial lung disease with clinical evidence, such as interstitial pneumonia and pulmonary fibrosis features on baseline CT scans

• known or concurrent bleeding disorders or other uncontrolled diseases contraindicating surgical treatment

• physical examination or clinical trial findings that can interfere with the results or put the patient at increased risk for treatment complications

• comorbidities, including chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, and unstable mental disorders requiring therapy

• allergy to drugs used in the study

• participation in other clinical trials within 30 days before enrollment

• ineligibility for participation based on the decision of investigators.