NCT06303583
Enrolling by Invitation
Phase 1
Neoadjuvant Chemoradiotherapy Followed by Sequential Immunotherapy for Thoracic Esophageal Squamous Cell Carcinoma
Qiu Guoqin1 site in 1 country30 target enrollmentJune 1, 2022
ConditionsEsophageal Squamous Cell Carcinoma
Overview
- Phase
- Phase 1
- Intervention
- paclitaxel
- Conditions
- Esophageal Squamous Cell Carcinoma
- Sponsor
- Qiu Guoqin
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Complete pathological response rate
- Status
- Enrolling by Invitation
- Last Updated
- 2 years ago
Overview
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.
Investigators
Qiu Guoqin
Chief Physician
Zhejiang Cancer Hospital
Eligibility Criteria
Inclusion Criteria
- •Histology confirmed thoracic esophageal squamous cell carcinoma.
- •ECOG ps 0 to
- •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/m
- •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.
Arms & Interventions
IO
chemoradiotherapy sequential tislelizumab
Intervention: paclitaxel
IO
chemoradiotherapy sequential tislelizumab
Intervention: carboplatin
IO
chemoradiotherapy sequential tislelizumab
Intervention: tislelizumab
IO
chemoradiotherapy sequential tislelizumab
Intervention: radiotherapy
Outcomes
Primary Outcomes
Complete pathological response rate
Time Frame: 1 year
Secondary Outcomes
- 2-year overall survival rate(2 years)
- 2-year Disease-free survival rate(2 years)
- Safety will be analyzed through the incidence of adverse events, serious adverse events(Up to 28 days from last dose)
- R0 resection rate(1 year)
Study Sites (1)
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