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

Last updated: February 7, 2024
Sponsor: Sun Yat-sen University
Overall Status: Active - Not Recruiting

Phase

2

Condition

Esophageal Disorders

Squamous Cell Carcinoma

Lung Cancer

Treatment

radiation therapy at a total dose 50 Gy

Toripalimab

radiation therapy at a total dose 60 Gy

Clinical Study ID

NCT04844385
GASTO-1071
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • histologically confirmed esophageal squamous cell carcinoma
  • patients have measurable or evaluable lesions based on the Response EvaluationCriteria in Solid Tumors (RECIST) criteria
  • unresectable T1-4 N0-3 M0-1 confirmed by CT or MRI (M1 only includes patients withlymph 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≥60ml/min
  • bilirubin ≤1.5 times UNL, AST(SGOT)≤2.5 times UNL ,ALT(SGPT)≤2.5 times UNL,alkalinephosphatase ≤5 times UNL
  • FEV1 >0.8 L
  • CB6 within normal limits
  • patients and their family signed the informed consents

Exclusion

Exclusion Criteria:

  • previous or recent another malignancy, except for nonmelanoma skin cancer or cervicalcancer in situ
  • contraindication for chemotherapy
  • women in pregnancy, lactation period, or no pregnancy test 14 days before the firstdose
  • 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

Study Design

Total Participants: 124
Treatment Group(s): 6
Primary Treatment: radiation therapy at a total dose 50 Gy
Phase: 2
Study Start date:
February 20, 2021
Estimated Completion Date:
December 20, 2024

Study Description

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.

All patients were planned to receive 2 cycle of toripalimab plus paclitaxel/nedaplatin as neoadjuvant therapy. Then they all receive radical dose of chest radiation and concurrent chemotherapy of capecitabine (PO 1000 mg/m2, bid, d1-d14, q3w).

Connect with a study center

  • Sun yat-sen University Cancer Center

    Guangzhou, Guangdong 510000
    China

    Site Not Available

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