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

NCT06303583 | Enrolling By Invitation Phase 1

• 1 other identifier: IRB- 2022-213
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Neoadjuvant; chemoradiotherapy; tislelizumab

Outcome Measures

Primary Outcomes (1)

• Complete pathological response rate

  1 year

Secondary Outcomes (4)

• R0 resection rate

  1 year

• 2-year Disease-free survival rate

  2 years

• 2-year overall survival rate

  2 years

• Safety will be analyzed through the incidence of adverse events, serious adverse events

  Up to 28 days from last dose

Study Arms (1)

IO

EXPERIMENTAL

chemoradiotherapy sequential tislelizumab

Drug: paclitaxel; Drug: carboplatin; Drug: tislelizumab; Radiation: radiotherapy

Interventions

paclitaxel DRUG

paclitaxel, 50 mg/m2, QW\*5

IO

carboplatin DRUG

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

IO

tislelizumab DRUG

200mg Q3W, 2cycles

IO

radiotherapy RADIATION

41.4Gy in 23 fractions

IO

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qiu Guoqin: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Paclitaxel; Carboplatin; tislelizumab; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: June 1, 2022
• Primary Completion: August 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)