Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

NCT04844385 | Active Not Recruiting Phase 2

• 1 other identifier: GASTO-1071
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase II non-randomized study is to determine the efficacy and toxicity of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced unresectable esophageal squamous cell carcinoma.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Toripalimab, Neoadjuvant, Concurrent Chemoradiotherapy, Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• progression-free survival rate

  18-month

Secondary Outcomes (6)

• overall survival rate

  18-month

• Clinical response rate

  2 months after radiotherapy

• the rate of grade 3 or 4 toxicities according to CTCAE4.0

  1 year after therapy

• distant metastasis-free survival

  18-month

• locoregional recurrence-free survival

  18-month

Study Arms (2)

Cohort A

EXPERIMENTAL

Patients in cohort A receive 2 cycles Toripalimab plus Paclitaxel/Nedaplatin, followed by radiotherapy at a total dose of 60Gy combined with Capecitabine.

Drug: Toripalimab; Drug: Paclitaxel-albumin; Drug: Nedaplatin; Radiation: radiation therapy at a total dose 60 Gy; Drug: Capecitabine

Cohort B

EXPERIMENTAL

Patients in cohort B receive 2 cycles Toripalimab plus Paclitaxel/Nedaplatin, followed by radiotherapy at a total dose of 50Gy combined with Capecitabine.

Drug: Toripalimab; Drug: Paclitaxel-albumin; Drug: Nedaplatin; Drug: Capecitabine; Radiation: radiation therapy at a total dose 50 Gy

Interventions

Toripalimab DRUG

Toripalimab 240 mg, d1, Q3w for two cycles

Cohort A; Cohort B

Paclitaxel-albumin DRUG

Paclitaxel-albumin 260 mg/m2, d1, Q3w for two cycles

Cohort A; Cohort B

Nedaplatin DRUG

Nedaplatin 75mg/m2, d1, Q3w for two cycles

Cohort A; Cohort B

radiation therapy at a total dose 60 Gy RADIATION

Radiation therapy at a total dose 60 Gy

Cohort A

Capecitabine DRUG

Capecitabine 1000 mg/m2, bid, d1-14, q3w during radiotherapy

Cohort A; Cohort B

radiation therapy at a total dose 50 Gy RADIATION

Radiation therapy at a total dose 50 Gy

Cohort B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed esophageal squamous cell carcinoma
• patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
• unresectable T1-4 N0-3 M0-1 confirmed by CT or MRI (M1 only includes patients with lymph node metastasis in the supraclavicular region)
• ECOG performance status 0-1
• no previous chest radiotherapy, immunotherapy or biotherapy.
• hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
• serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
• bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
• FEV1 \>0.8 L
• CB6 within normal limits
• patients and their family signed the informed consents

You may not qualify if:

• previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
• contraindication for chemotherapy
• women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
• women who has the probability of pregnancy without contraception
• tendency of hemorrhage
• in other clinical trials within 30 days
• addicted in drugs or alcohol, AIDS patients
• uncontrollable seizure or psychotic patients without self-control ability
• severe allergy or idiosyncrasy
• not suitable for this study judged by researchers

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

Location

Related Publications (14)

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• Liu F, Wang D, Rong Y, Wei S, SiTu Y, Wang M, Zhang H, Zhang P, Zheng S, Yin S, Xie C, Hu Y, Qiu B, Liu H. Safety and efficacy of neoadjuvant toripalimab plus chemotherapy followed by chemoradiotherapy for locally advanced esophageal squamous cell carcinoma in China (GASTO 1071): a non-randomised, two-cohort, phase 2 trial. EClinicalMedicine. 2025 Apr 5;82:103184. doi: 10.1016/j.eclinm.2025.103184. eCollection 2025 Apr.

  PMID: 40242562 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

toripalimab; nedaplatin; Capecitabine

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)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Hui Liu, Professor

  Sun yat-sen universtiy cancer center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: April 14, 2021
• Study Start: February 20, 2021
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

CN (1)