Immunochemotherapy ± Salvage Chemoradiation for Local Recurrence of Esophageal Squamous Cell Carcinoma After Definitive Chemoradiotherapy

NCT ID: NCT07016737

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2029-09-01

Brief Summary

The combination of programmed death receptor 1 (PD-1) inhibitors with chemotherapy has been recognized for the treatment of advanced and metastatic esophageal squamous cell carcinoma (ESCC). To the best of our knowledge, there is no published report to date which analyzes the efficacy and safety of this regimen in the treatment of locally primary-recurrent ESCC patients after definitive chemoradiotherapy or radiotherapy only. This is a prospective clinical study designed to enroll 79 patients. The study will focus on those who have attained a complete response (CR) subsequent to definitive chemoradiotherapy or radiotherapy and have a histologically proven in-field recurrence, with no distant metastases. These patients will receive treatment with a PD-1 inhibitor combined with monotherapy chemotherapy for 4 cycles, followed by a 2-year maintenance treatment with PD-1 inhibitors. During this period, patients diagnosed with esophageal wall thickening and identified as having progressive disease (PD) have the option to undergo salvage radiotherapy in conjunction with a dual-agent chemotherapy for 5 cycles. The primary endpoint of is 2-year after recurrence survival (ARS) rate. The secondary endpoints include the progression-free survival (PFS) and safety.

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Group

This is a prospective clinical study designed to enroll 79 patients. The study will focus on those who have attained a complete response (CR) subsequent to definitive chemoradiotherapy or radiotherapy and have a histologically proven in-field recurrence, with no distant metastases. These patients will receive treatment with a PD-1 inhibitor (sintilimab or camrelizumab 200mg, d1, q3w) combined with monotherapy chemotherapy (paclitaxel 175mg/m2 or docetaxel 75mg/m2 or irinotecan 270mg/m2, d1, q3w) for 4 cycles, followed by a 2-year maintenance treatment with PD-1 inhibitors. During this period, patients diagnosed with esophageal wall thickening and identified as having progressive disease (PD) have the option to undergo salvage radiotherapy (45-50.4 Gy/25-28/F/5-5.5 weeks) in conjunction with a dual-agent chemotherapy (paclitaxel 50 mg/m2, d1 + carboplatin AUC 2, d1, qw) for 5 cycles.

Group Type: EXPERIMENTAL

Sintilimab Combined With Docetaxel Monotherapy

Intervention Type: DRUG

79 patients will receive treatment with a PD-1 inhibitor (sintilimab or camrelizumab 200mg, d1, q3w) combined with monotherapy chemotherapy (paclitaxel 175mg/m2 or docetaxel 75mg/m2 or irinotecan 270mg/m2, d1, q3w) for 4 cycles, followed by a 2-year maintenance treatment with PD-1 inhibitors. During this period, patients diagnosed with esophageal wall thickening and identified as having progressive disease (PD) have the option to undergo salvage radiotherapy (45-50.4 Gy/25-28/F/5-5.5 weeks) in conjunction with a dual-agent chemotherapy (paclitaxel 50 mg/m2, d1 + carboplatin AUC 2, d1, qw) for 5 cycles.

Interventions

Sintilimab Combined With Docetaxel Monotherapy

79 patients will receive treatment with a PD-1 inhibitor (sintilimab or camrelizumab 200mg, d1, q3w) combined with monotherapy chemotherapy (paclitaxel 175mg/m2 or docetaxel 75mg/m2 or irinotecan 270mg/m2, d1, q3w) for 4 cycles, followed by a 2-year maintenance treatment with PD-1 inhibitors. During this period, patients diagnosed with esophageal wall thickening and identified as having progressive disease (PD) have the option to undergo salvage radiotherapy (45-50.4 Gy/25-28/F/5-5.5 weeks) in conjunction with a dual-agent chemotherapy (paclitaxel 50 mg/m2, d1 + carboplatin AUC 2, d1, qw) for 5 cycles.

Intervention Type: DRUG

Other Intervention Names

Sintilimab Combined With Paclitaxel Monotherapy; Sintilimab Combined With Irinotecan Monotherapy; Camrelizumab Combined With Docetaxel Monotherapy; Camrelizumab Combined With Paclitaxel Monotherapy; Camrelizumab Combined With Irinotecan Monotherapy; Paclitaxel Combined With Carboplatin; salvage radiotherapy; Omeprazole; Dexamethasone; Smectite Powder; Loperamide Hydrochloride Capsules; Atropine Hydrochloride; Computed Tomography; Positron Emission Tomography - Computed Tomography; Ultrasound; Gastroscopy; Digital Gastrointestinal Radiography

Eligibility Criteria

Inclusion Criteria

-1.Age ≥18 years, regardless of gender. 2.Pathologically confirmed local recurrence of esophageal squamous cell carcinoma after definitive chemoradiotherapy.

3.With or without regional lymph node metastasis, but no distant metastasis. 4.Ineligible for surgery or refusal to undergo surgical intervention. 5.Tolerance to chemotherapy, radiotherapy, and immunotherapy. 6.ECOG performance status 0-2. 7.Life expectancy ≥3 months. 8.No severe hematopoietic, cardiac, pulmonary, hepatic, renal dysfunction, or immunodeficiency.

Exclusion Criteria

• 1. Esophageal perforation or hematemesis. 2.Distant metastasis in patients after definitive chemoradiotherapy. 3.History of drug abuse, chronic alcoholism, or HIV/AIDS. 4.Myocardial infarction within ≤6 months. Patients with myocardial infarction >6 months ago must undergo myocardial thallium scan to confirm absence of myocardial ischemia and obtain cardiologist approval for chemotherapy.

5.Uncontrolled seizures or psychiatric disorders impairing decision-making capacity.

6.Severe allergic history or hypersensitivity. 7.Other conditions deemed unsuitable for study participation by the investigator.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ye jinjun

OTHER

Sponsor Role: lead

Responsible Party

Ye jinjun

Chief Physician, M.D.

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ye jin jiun

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Cancer Institute & Hospital

Locations

Jiangsu Provincial Cancer Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

2024-008-01

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024-008-01

Identifier Type: -

Identifier Source: org_study_id