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Enrolling by invitation NCT06303583

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

Phase I / Phase II Interventional Esophageal Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: paclitaxel, carboplatin, tislelizumab, radiotherapy.
Who it may be relevant to
Registry conditions: Esophageal Squamous Cell Carcinoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug paclitaxel
    paclitaxel, 50 mg/m2, QW\*5
  • Drug carboplatin
    area under the curve of2mg/mL/min, QW\*5
  • Drug tislelizumab
    200mg Q3W, 2cycles
  • Radiation radiotherapy
    41.4Gy in 23 fractions

Primary outcome measures

  • Complete pathological response rate [Time frame: 1 year]
Secondary outcome measures (4)
  • R0 resection rate [Time frame: 1 year]
  • 2-year Disease-free survival rate [Time frame: 2 years]
  • 2-year overall survival rate [Time frame: 2 years]
  • Safety will be analyzed through the incidence of adverse events, serious adverse events [Time frame: Up to 28 days from last dose]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zhejiang Cancer Hospital — Hangzhou

Identifiers

NCT: NCT06303583 · IRB- 2022-213

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗