Clinical trial NCT07016737: Immunochemotherapy ± Salvage Chemoradiation for Local Recurrence of Esophageal Squamous Cell Carcinoma After Definitive Chemoradiotherapy
Official title: Immunochemotherapy ± Salvage Chemoradiation for Local Recurrence of Esophageal Squamous Cell Carcinoma After Definitive Chemoradiotherapy (ESO-Nanjing12)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
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
Lead sponsor: Jiangsu Cancer Institute & Hospital
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 2-year ARS rate
timeFrame: From date of Immunochemotherapy until the date of death from any cause, assessed up to 24 months
Secondary outcomes:
measure: progression-free survival (PFS)
timeFrame: 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
measure: safety assessed by adverse events (TEAEs)
timeFrame: Up to 2 years after treatment initiation until new treatment
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jiangsu Provincial Cancer Hospital
state: Jiangsu
Study officials:
affiliation: Jiangsu Cancer Institute & Hospital
name: Ye jin jiun
role: PRINCIPAL_INVESTIGATOR
References: