Dynamic Changes of CtDNA to Evaluate the Efficacy of Immunoconsolidation Therapy After Radiotherapy and Chemotherapy for Esophageal Cancer

Not Applicable

Recruiting

• Conditions: Esophageal Cancer; CtDNA

• Registration Number: NCT06792786
• Lead Sponsor: The Central Hospital of Lishui City

Brief Summary

The incidence and mortality of esophageal squamous cell carcinoma are among the highest in China, and most patients are diagnosed in the middle and late stages. Concurrent chemoradiotherapy is the standard treatment for unresectable locally advanced esophageal squamous cell carcinoma. The 5-year formation rate of advanced esophageal cancer is less than 20%. Immunotherapy for advanced esophageal squamous cell carcinoma has definite efficacy and low toxicity, and the results of combined radiotherapy have also been preliminarily reported. Combined immunotherapy after chemoradiotherapy for esophageal cancer is a feasible combination program. But immunotherapy still lacks ideal biomarkers to screen people for advantage. ctDAN status can accurately guide treatment implementation and predict tumor progression. Studies have shown that ctDNA changes are earlier than imaging findings of recurrence or metastasis, and ctNDA detection can sensitively predict tumor progression and prognosis. Therefore, it is necessary to dynamically monitor the changes of ctDNA in immunoconsolidation therapy after radical radiotherapy and chemotherapy for esophageal cancer, and explore its correlation with the curative effect and prognosis of radical radiotherapy and chemotherapy for esophageal cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-12-10
• Status Verified: 2025-01
• Study First Submitted: 2025-01-20
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Primary Completion: 2027-05-31
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

-1. Age 18-75 years old, male or female; 2.ECOG score 0 ~ 1; 3. Esophageal squamous cell carcinoma was confirmed by pathology. 4. No radiotherapy, chemotherapy or other treatment was given before enrollment; 5. AJCC 8th stage II-IVa, which cannot be treated by surgical evaluation or patients reject operation; 6. Has sufficient organ function, (1) Blood routine: Peripheral blood white blood cell count ≥3.0×10^9 / L, neutrophil absolute value ≥1.5×10^9 /L, hemoglobin ≥90 g/L, platelets ≥75×10^9 / L (No blood transfusion and blood products within 14 days, no use of G-CSF and other blood-stimulating factors to correct), (2) Liver function: total bilirubin ≤1.5× upper limit of normal(ULN), AST and ALT≤2.5× ULN, alkaline phosphatase ≤5× ULN, (3) Renal function: Serum creatinine ≤1.0× ULN or crcl ≥50 ml/min, (4) Adequate haemostasis laboratory data prior to randomization: INR or PT ≤1.5×ULN (If the subject was receiving anticoagulant therapy, as long as the PT was within the intended use range of anticoagulant drugs) (5) Myocardial enzymes were within the normal range.

7. Sign a consent form.

Exclusion Criteria

• 1. unable to provide a sufficient number of tissue samples/blood samples for the study prior to treatment; 2. The patient refused to accept dynamic ctDNA testing; 3. A history of malignant tumors other than esophageal cancer in the past 5 years (excluding cured local tumors such as cervical carcinoma in situ, basal cell carcinoma, and prostate carcinoma in situ); 4. A history of gastrointestinal bleeding within the past 6 months, or abnormal coagulation at enrollment, or currently receiving thrombolytic or anticoagulant therapy, indicating a higher risk of bleeding; 5. Severe cardiovascular and cerebrovascular diseases; 6. History of interstitial lung disease or active pneumonia/tuberculosis; 7. Severe allergic reaction to paclitaxel/cisplatin chemotherapeutics or any monoclonal antibody; 8. Other conditions deemed unsuitable for participation in this study by the investigator.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	two years	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.

Secondary Outcome Measures

Name	Time	Method
locoregional progression-free survival (LRPFS)	2 years	locoregional progression-free survival (LRPFS) is defined as the time from treatment to the primary tumor or regional lymph node histopathological progressconfirmed on CT. In the absence of pathology, tumor progression is evident under gastroscopy and/or confirmed by imaging such as PET-CT.
Overall survival (OS)	2 years	Overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence

Trial Locations

Locations (2)

Jinhua Municipal Central Hospital; 🇨🇳 Jinhua, Zhejiang, China

The central Hospital of Lishui City; 🇨🇳 Lishui, Zhejiang, China