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

February 7, 2024 updated by: Hui Liu, Sun Yat-sen University

A Prospective Single-arm Phase Ⅱ Study of Toripalimab Plus Neoadjuvant Chemotherapy Combined With Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A
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
Toripalimab 240 mg, d1, Q3w for two cycles
Drug: Paclitaxel-albumin
Paclitaxel-albumin 260 mg/m2, d1, Q3w for two cycles
Drug: Nedaplatin
Nedaplatin 75mg/m2, d1, Q3w for two cycles
Drug: Capecitabine
Capecitabine 1000 mg/m2, bid, d1-14, q3w during radiotherapy
Radiation: radiation therapy at a total dose 60 Gy
Radiation therapy at a total dose 60 Gy
Experimental: Cohort B
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
Toripalimab 240 mg, d1, Q3w for two cycles
Drug: Paclitaxel-albumin
Paclitaxel-albumin 260 mg/m2, d1, Q3w for two cycles
Drug: Nedaplatin
Nedaplatin 75mg/m2, d1, Q3w for two cycles
Drug: Capecitabine
Capecitabine 1000 mg/m2, bid, d1-14, q3w during radiotherapy
Radiation: radiation therapy at a total dose 50 Gy
Radiation therapy at a total dose 50 Gy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival rate
Time Frame: 18-month
18-month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response rate
Time Frame: 2 months after radiotherapy
the percentage of patients who had partial remission or complete remission after therapy
2 months after radiotherapy
the rate of grade 3 or 4 toxicities according to CTCAE4.0
Time Frame: 1 year after therapy
the percentage of patients who develop grade 3 or 4 toxicities
1 year after therapy
overall survival rate
Time Frame: 18-month
18-month
distant metastasis-free survival
Time Frame: 18-month
18-month
locoregional recurrence-free survival
Time Frame: 18-month
18-month
Quality of life assessed by QLQ-C30
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Hui Liu, Professor, Sun yat-sen universtiy cancer center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2021

Primary Completion (Estimated)

December 20, 2024

Study Completion (Estimated)

December 20, 2024

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 14, 2021

Study Record Updates

Last Update Posted (Estimated)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GASTO-1071

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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