Toripalimab With Neoadjuvant Chemotherapy for Locally Advanced Esophageal Squamous Cell Carcinoma

NCT04177797 | Unknown Phase 2

• 1 other identifier: SCCH-TS2001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-institution, single arm trial of Toripalimab with neoadjuvant carboplatin and paclitaxel for locally advanced esophageal squamous cell carcinoma (ESCC).The primary study hypothesis is that the patients who received Toripalimab combined with carboplatin and paclitaxel will increase complete pathologic response rate.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

Esophageal squamous cell carcinoma; Toripalimab; Neoadjuvant treatment; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• Complete pathologic response rate

  Definition of complete pathologic response is "no cancer cell, including lympho nodes" which corresponds with tumor regression score 0. Definition of pathologic response is as follows. Tumor regression score Grade 0 and 1 will be defined as "responder" and 2 and 3 will be considered as "non-responders"

  3 months

Secondary Outcomes (3)

• Disease control rate

  3 months

• Objective response rate

  3 months

• Incidence of adverse events

  6 months

Study Arms (1)

Toripalimb

EXPERIMENTAL

Single arm, non randomized, open label study.The patients will receive Toripalimb concurrently caboplatin and paclitaxel treatment.

Drug: Toripalimab

Interventions

Toripalimab DRUG

Two cycles of Toripalimab(240 mg administered as an intravenous infusion over 30 minutes per 3 weeks), concurrently paclitaxel(135 mg/m2) and carboplatin(AUC 5) administered as an intravenous infusion per 3 weeks.

Toripalimb

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed ESCC;
• Clinical stage T1-2N2-3M0 or T3N1-3M0 or T4N0-3M0(AJCC 8 TNM classification);
• Have a performance status of 0 or 1 on the ECOG Performance Scale;
• The important organs functions meet the following requirements:the absolute neutrophil count(ANC) ≥1.5×109/L; the platelet count ≥100×109/L; hemoglobin ≥90g/L; bilirubin is less than or equal to 1.5 times ULN, ALT and AST less than or equal 2.5 times UILN; creatinine clearance rate(CCr) ≥50mL/min; the thyroid function is normal;
• Expected survival time is greater than or equal to 3 months;
• Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
• Female subjects of childbearing potential must be willing to use an adequate method of contraception - Contraception, for the course of the study through 90 days after the last dose of study medication;
• Be willing and able to provide written informed consent/assent for the trial.

You may not qualify if:

• Has any active autoimmune disease or a history of autoimmune disease;
• The patient is receiving systemic steroid therapy or any other form of immunosuppressive therapy;
• The patient had active infection, fever of unknown cause ≥38.5℃ within 7 days before the medication, or white blood cell count at baseline \>15×109/L;
• The patient had previously received other anti-pd-1 antibody therapy or other immunotherapy targeting pd-1 / pd-L1,or received chemoradiotherapy;
• Have a history of mental illness or psychiatric substance abuse;
• Patients who had participated in clinical trials of other drugs within 4 weeks;
• Patients with a serious risk to treating patients' safety or a concomitant disease that affects the completion of the study according to the researchers judgment;
• Senior or uncontrolled virus injection: HIV, TP, hepatitis virus;

Sponsors & Collaborators

• Sichuan Cancer Hospital and Research Institute: lead

Study Sites (1)

Sichuan Cancer Hospital and Research Institute

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• He W, Leng X, Mao T, Luo X, Zhou L, Yan J, Peng L, Fang Q, Liu G, Wei X, Wang K, Wang C, Zhang S, Zhang X, Shen X, Huang D, Yi H, Bei T, She X, Xiao W, Han Y. Toripalimab Plus Paclitaxel and Carboplatin as Neoadjuvant Therapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma. Oncologist. 2022 Feb 3;27(1):e18-e28. doi: 10.1093/oncolo/oyab011.

  PMID: 35305102 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

toripalimab

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,Head of Thoracic Surgery

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: November 26, 2019
• Study Start: March 20, 2020
• Primary Completion: June 16, 2020
• Study Completion: December 31, 2023
• Last Updated: February 9, 2022

Record last verified: 2022-02

Locations

CN (1)