Neoadjuvant Chemoradiotherapy Followed by Sequential Immunotherapy for Thoracic Esophageal Squamous Cell Carcinoma

Trial Title: Neoadjuvant Chemoradiotherapy Followed by Sequential Immunotherapy for Thoracic Esophageal Squamous Cell Carcinoma

NCT ID: NCT06303583

Condition: Esophageal Squamous Cell Carcinoma

Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Carboplatin
Tislelizumab

Conditions: Keywords:
Neoadjuvant
chemoradiotherapy
tislelizumab

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Enrolling by invitation

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: paclitaxel
Description: paclitaxel, 50 mg/m2, QW*5
Arm group label: IO

Intervention type: Drug
Intervention name: carboplatin
Description: area under the curve of2mg/mL/min, QW*5
Arm group label: IO

Intervention type: Drug
Intervention name: tislelizumab
Description: 200mg Q3W, 2cycles
Arm group label: IO

Intervention type: Radiation
Intervention name: radiotherapy
Description: 41.4Gy in 23 fractions
Arm group label: IO

Summary: The purpose of study is to investigate the safety and efficacy of sequential immunotherapy with neoadjuvant chemoradiotherapy for esophageal cancer

Detailed description: This is a single-arm, phase Ib study. Eligibility criteria include histologically confirmed ESCC and clinical T3-4aN0M0 or T2-4aN+M0 (AJCC/UICC 8). Patients received neoadjuvant radiotherapy (41.4Gy in 23 fractions) with concurrent chemotherapy (paclitaxel, 50 mg/m2, carboplatin area under the curve of 2mg/mL/min, QW*5). Then followed by two cycles of tislelizumab (200mg, Q3W). The primary endpoint was the pathological complete response (pCR) rate and safety.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Ages 18-75. - Histology confirmed thoracic esophageal squamous cell carcinoma. - ECOG ps 0 to 1. - Resectable or potentially resectable T2-4aN0 or T1-4aN+ patients (AJCC/UICC Clinical Staging of Esophageal squamous cell Carcinoma, 8th edition (cTMN)). - Length of esophageal lesions <8cm. - There were no surgical contraindications. - Neutrophil count ≥1.5*109/L, platelet count ≥10.0*109/L, hemochrome ≥9g/dL; Serum creatinine ≤1.5 times the upper limit of normal value; Bilirubin ≤1.5 times the upper limit of normal value, AST, ALT, AKP≤2.5 times the upper limit of normal value. - BMI acuity 18.5 kg/m2. - Informed notification and signed informed consent. Exclusion Criteria: - Cervical esophageal cancer (upper part of the lesion in the cervical esophagus). Multifocal esophageal carcinoma, lesion length >8cm. - Trachea and aorta were invaded (Annex 5). - Hoarseness caused by the tumor. - Esophageal fistula. - Lymph node metastasis in the neck and periceliac artery (AJCC/UICC 8th edition esophageal/esophagogastric junction region lymph node division 1 and 20). - A history of active autoimmune disorders or syndromes requiring treatment with systemic steroids or immunosuppressants (except for vitiligo or cured childhood asthma/allergies who do not require any intervention in adulthood; Autoimmune hypothyroidism treated with a stable dose of thyroid replacement hormone). - She is on hormonal or immunosuppressive therapy. - He's had an organ transplant. - HIV infection, hepatitis C (hepatitis C antibody positive with HCV-RNA above the detection limit of the assay), chronic active hepatitis B (HBV DNA≥2×103IU/ml or >1×104copies/mL). - Active tuberculosis, interstitial pneumonia, active infection, poorly controlled diabetes, symptomatic arrhythmia, symptomatic new dysfunction, myocardial infarction, active peptic ulcer, chronic active enteritis within 6 months; Affected during pregnancy or lactation. - Major surgery in the last three months. - Severe diabetes mellitus with poor drug control, symptomatic arrhythmia, symptomatic cardiac insufficiency, myocardial infarction within 6 months, chronic active enteritis, chronic nephritis. QTc acuity 470 ms. - He had a history of malignancy. Previously received chemotherapy, radiotherapy, targeted therapy, immunotherapy and other antitumor therapies. - Patients with allergic or contraindicated taxa. - Live vaccine is administered within 30 days before the first dose of immunotherapy. - Refusal or inability to sign up for ICF study. - The investigator decided that the patient was not suitable to participate.

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Zhejiang Cancer Hospital

Address:
City: Hangzhou
Zip: 310000
Country: China

Start date: June 1, 2022

Completion date: December 31, 2026

Lead sponsor:
Agency: Qiu Guoqin
Agency class: Other

Source: Zhejiang Cancer Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06303583