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

NCT ID: NCT06303583

Last Updated: 2024-03-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

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

Study Groups

IO

chemoradiotherapy sequential tislelizumab

Group Type: EXPERIMENTAL

paclitaxel

Intervention Type: DRUG

paclitaxel, 50 mg/m2, QW\*5

carboplatin

Intervention Type: DRUG

area under the curve of2mg/mL/min, QW\*5

tislelizumab

Intervention Type: DRUG

200mg Q3W, 2cycles

radiotherapy

Intervention Type: RADIATION

41.4Gy in 23 fractions

Interventions

paclitaxel

paclitaxel, 50 mg/m2, QW\*5

Intervention Type: DRUG

carboplatin

area under the curve of2mg/mL/min, QW\*5

Intervention Type: DRUG

tislelizumab

200mg Q3W, 2cycles

Intervention Type: DRUG

radiotherapy

41.4Gy in 23 fractions

Intervention Type: RADIATION

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.

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

Sponsors

Qiu Guoqin

OTHER

Sponsor Role: lead

Responsible Party

Qiu Guoqin

Chief Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

IRB- 2022-213

Identifier Type: -

Identifier Source: org_study_id