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

NCT07016737 | Enrolling By Invitation Phase 3 DMC

• 1 other identifier: 2024-008-01
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

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)

Keywords

Esophageal squamous cell carcinoma; Local recurrence at the primary tumor site; Programmed cell death protein 1; Salvage Chemoradiotherapy; Immunochemotherapy

Outcome Measures

Primary Outcomes (1)

• 2-year ARS rate

  the proportion of patients surviving 2 years from the time of recurrence

  From date of Immunochemotherapy until the date of death from any cause, assessed up to 24 months

Secondary Outcomes (2)

• progression-free survival (PFS)

  From date of Immunochemotherapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

• safety assessed by adverse events (TEAEs)

  Up to 2 years after treatment initiation until new treatment

Study Arms (1)

Experimental Group

EXPERIMENTAL

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.

Drug: Sintilimab Combined With Docetaxel Monotherapy

Interventions

Sintilimab Combined With Docetaxel Monotherapy 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.

Also known as: 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

Experimental Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \. 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.
• Uncontrolled seizures or psychiatric disorders impairing decision-making capacity.
• Severe allergic history or hypersensitivity. 7.Other conditions deemed unsuitable for study participation by the investigator.

Sponsors & Collaborators

• Ye jinjun: lead

Study Sites (1)

Jiangsu Provincial Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Carboplatin; Omeprazole; Dexamethasone; Loperamide; atropine sulfate-diphenoxylate hydrochloride drug combination; High-Energy Shock Waves; Gastroscopy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Piperidines; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Ye jin jiun

  Jiangsu Cancer Institute & Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician, M.D.

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 12, 2025
• Study Start: August 1, 2024
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)