A Multicenter Prospective Study Evaluating Concurrent Chemoradiotherapy Following Induction Immunochemotherapy for Esophageal Cancer Based on Dynamic ctDNA Monitoring

NCT06792786 | Recruiting

• 1 other identifier: ZJLSRT002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Esophageal squamous cell carcinoma (ESCC) continues to exhibit high incidence and mortality rates in China, with the majority of patients diagnosed at middle to advanced stages. Concurrent chemoradiotherapy (CCRT) is the standard treatment for unresectable locally advanced ESCC. The 5-year survival rate for advanced esophageal cancer remains below 20%. Immunotherapy has demonstrated definitive efficacy and a favorable toxicity profile in advanced ESCC, and preliminary results of its combination with radiotherapy have been reported. Induction immunochemotherapy followed by concurrent chemoradiotherapy represents a feasible combined treatment strategy. However, optimal biomarkers to identify patients who would benefit from this approach are still lacking. Circulating tumor DNA (ctDNA) status can accurately guide treatment implementation and predict tumor progression. Studies have shown that ctDNA changes precede imaging evidence of recurrence or metastasis, and ctDNA detection can sensitively predict tumor progression and prognosis. Therefore, it is necessary to dynamically monitor ctDNA changes throughout the course of induction immunochemotherapy followed by radical concurrent chemoradiotherapy in esophageal cancer and explore its correlation with prognosis.

Conditions

Esophageal Cancer; ctDNA

Keywords

esophageal cancer; ctDNA; chemoradiotherapy; induction immunochemotherapy; prognosis

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  We aim to evaluate the progression-free survival (PFS) of patients with unresectable esophageal squamous cell carcinoma who accept concurrent chemoradiotherapy and received sequential treatment with Triptolide injection after radiotherapy.

  one year

Study Arms (1)

Induction immunochemotherapy followed by radical concurrent chemoradiotherapy

EXPERIMENTAL

This is a single-arm, non-randomized study Diagnostic Tests: ctDNA Analysis Dynamic monitoring of ctDNA changes in patients with esophageal cancer.

Diagnostic Test: Induction Immunochemotherapy

Interventions

Induction Immunochemotherapy DIAGNOSTIC_TEST

Induction Immunochemotherapy:Toripalimab 240 mg (immunotherapy) combined with paclitaxel (135 mg/m²) and cisplatin (75 mg/m²) chemotherapy, administered every 3 weeks for 2 cycles. Other Names: - Radiotherapy: 95% PTV 50-50.4 Gy/25-28 fractions, 1.8-2 Gy/fraction; 5 days per week. - Chemotherapy: Weekly paclitaxel (50 mg/m²) combined with cisplatin (25 mg/m²) for 5 cycles. ctDNA Analysis:Initial tissue and blood ctDNA testing prior to treatment (T0) is based on next-generation sequencing (NGS) technology, utilizing tumor-informed assays. Blood ctDNA samples will be collected before chemoradiotherapy, after 20 fractions of radiotherapy, and every 3 months following completion of chemoradiotherapy.

Induction immunochemotherapy followed by radical concurrent chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All subjects must sign an informed consent form before initiating any study-related procedures;
• All patients must be aged ≥18 years and ≤75 years;
• Histologically or cytologically confirmed esophageal cancer (squamous cell carcinoma);
• Clinical stage II-IVa, assessed by a surgeon as inoperable, or patient refusal of surgery;
• No prior radiotherapy, chemotherapy, immunotherapy, or biotherapy for esophageal cancer;
• ECOG performance status of 0-1;
• Laboratory test values within the following limits before the first dose of the investigational drug:
• Hematology: WBC ≥3.0×10⁹/L; ANC ≥1.5×10⁹/L; PLT ≥70×10⁹/L; HGB ≥9.0 g/dL;
• Liver function: AST ≤2.5×ULN; ALT ≤2.5×ULN;
• Renal function: Cr ≤1.5×ULN or CrCl ≥40 mL/min;
• Coagulation: INR ≤1.5, APTT ≤1.5×ULN;
• Other: Lipase ≤1.5×ULN, unless clinically/radiographically insignificant if lipase \>1.5×ULN.

You may not qualify if:

• Insufficient tissue/blood sample available before treatment as required for the study;
• Patient refusal to undergo dynamic ctDNA testing;
• The primary esophageal lesion is in close proximity to the tracheobronchial tree or major blood vessels, with an investigator-assessed high risk of perforation or major hemorrhage;
• History of malignancies other than esophageal carcinoma within the past 5 years (except for curatively treated localized tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or localized prostate cancer);
• History of gastrointestinal bleeding within the past 6 months, or coagulopathy at enrollment, or current thrombolytic or anticoagulant therapy indicating a high risk of bleeding;
• Severe cardiovascular or cerebrovascular diseases;
• History of interstitial lung disease or active pneumonia/tuberculosis;
• Severe allergic reactions to paclitaxel/cisplatin or any monoclonal antibody;
• Any other condition deemed inappropriate for participation in this study as judged by the investigator.

Sponsors & Collaborators

• People's Hospital of Quzhou: collaborator
• Jinhua Central Hospital: collaborator
• The Central Hospital of Lishui City: lead
• Affiliated Hospital of Jiaxing University: collaborator

Study Sites (2)

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, 321000, China

RECRUITING

The central Hospital of Lishui City

Lishui, Zhejiang, 323000, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Zhifeng Tian, MD

CONTACT

+8613515789419; tzf419@hotmail.com

Shubo Ding, MD

CONTACT

+8613750983285; jhyyys@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: January 27, 2025
• Study Start: December 10, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

CN (2)