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

NCT ID: NCT06792786

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-10
• Study Completion Date: 2027-12-30

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.

Conditions

Esophageal Cancer; CtDNA

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

chemoradiotherapy Sequential Toripalimab

Group Type: EXPERIMENTAL

ctDNA detection

Intervention Type: DIAGNOSTIC_TEST

dynamically monitor the changes of ctDNA in patients with esophageal cancer Radiation: Radiotherapy 95% PTV50-50.4Gy/25-28fractions, 1.8-2Gy/1 fractions; 5 days a week; 6 weeks. Chemotherapy:weekly paclitaxel (50mg/m²) in combination with carboplatin (AUC=2) chemotherapy, a total of 4-5 cycles.

Other Names:

Intensity-modulated radiotherapy (IMRT) Drug: Toripalimab Toripalimab (240 mg, intravenously infused) will be administered as the maintenance treatment every 3 weeks within 4 weeks after the completion of radiotherapy for 1 years or until progression, intolerable toxicity, or physician/patient decision

Other Names:

Immunotherapy ctDNA detection: The first tissue and blood ctDNA test (T0) before treatment is based on next generation sequencing (NGS) technology, and ctDNA test is based on tumor- prior analysis informed assays method. Blood ctDNA testing after chemoradiotherapy was performed every 3 months

Interventions

ctDNA detection

dynamically monitor the changes of ctDNA in patients with esophageal cancer Radiation: Radiotherapy 95% PTV50-50.4Gy/25-28fractions, 1.8-2Gy/1 fractions; 5 days a week; 6 weeks. Chemotherapy:weekly paclitaxel (50mg/m²) in combination with carboplatin (AUC=2) chemotherapy, a total of 4-5 cycles.

Other Names:

Intensity-modulated radiotherapy (IMRT) Drug: Toripalimab Toripalimab (240 mg, intravenously infused) will be administered as the maintenance treatment every 3 weeks within 4 weeks after the completion of radiotherapy for 1 years or until progression, intolerable toxicity, or physician/patient decision

Other Names:

Immunotherapy ctDNA detection: The first tissue and blood ctDNA test (T0) before treatment is based on next generation sequencing (NGS) technology, and ctDNA test is based on tumor- prior analysis informed assays method. Blood ctDNA testing after chemoradiotherapy was performed every 3 months

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinhua Municipal Central Hospital

OTHER

Sponsor Role: collaborator

The Central Hospital of Lishui City

OTHER

Sponsor Role: lead

Responsible Party

Zhifeng Tian,MD

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China

Site Status: RECRUITING

The central Hospital of Lishui City

Lishui, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhifeng Tian, MD

Role: CONTACT

tzf419@hotmail.com

+8613515789419

Shubo Ding, MD

Role: CONTACT

jhyyys@163.com

+8613750983285

Other Identifiers

ZJLSRT002

Identifier Type: -

Identifier Source: org_study_id