Clinical trial NCT06792786: Dynamic Changes of CtDNA to Evaluate the Efficacy of Immunoconsolidation Therapy After Radiotherapy and Chemotherapy for Esophageal Cancer
Official title: Multi-center Prospective Study of Immunoconsolidation Therapy After Chemoradiotherapy for Esophageal Cancer Based on CtDNA Dynamic Detection
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
CtDNA
Keywords: esophageal cancer
radiotherapy
chemotheropy化学疗法
Immunotherapy
ctDNA
Lead sponsor: The Central Hospital of Lishui City
Sponsor class: OTHER
Collaborators: name: Jinhua Municipal Central Hospital
First posted: 2025-01-27
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: two years
Secondary outcomes:
measure: locoregional progression-free survival (LRPFS)
timeFrame: 2 years
measure: Overall survival (OS)
timeFrame: 2 years
Other outcomes:
Locations:
city: Jinhua
country: China
facility: Jinhua Municipal Central Hospital
state: Zhejiang
city: Lishui
country: China
facility: The central Hospital of Lishui City
state: Zhejiang
Study officials:
References: