Neoadjuvant Toripalimab in the Treatment of Locally Advanced dMMR/MSI-H Gastric or Gastroesophageal Junction Adenocarcinoma：an Open-label, Single-arm，Multi-center，Phase II Trial

Sun Yat-sen University1 site in 1 country24 target enrollmentMarch 9, 2023

ConditionsGastric or Gastroesophageal Junction Adenocarcinoma

InterventionsPD-1 inhibitor

DrugsPD-1 inhibitor

Overview

Phase: Phase 2
Intervention: PD-1 inhibitor
Conditions: Gastric or Gastroesophageal Junction Adenocarcinoma
Sponsor: Sun Yat-sen University
Enrollment: 24
Locations: 1
Primary Endpoint: Pathological complete remission (pCR) rates
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-center, open phase II clinical trial to evaluate the tolerability, safety and efficacy of toriparib monotherapy in the treatment of locally advanced dMMR/MSI-H gastric or gastroesophageal junction adenocarcinoma.

Detailed Description

In this phase II study, eligible patients are enrolled to receive toripalimab 240mg, ivdrip, Q3W to evaluate the anti-tumor efficacy and safety. After 2 and 4 cycles of toripalimab treatment, tumors are assessed, and patients are assigned to receive surgery or withdraw from study according to their anti-tumor efficacy. For patients withdrawing from study, routine treatment would be given. For patients staying in study, toripalimab would be administered for up to 2 years.

Registry

clinicaltrials.gov

Start Date

March 9, 2023

End Date

December 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Dong sheng Zhang

Professor

Sun Yat-sen University

Eligibility Criteria

Inclusion Criteria

•Aged 18-75 years, regardless of gender
•Patients with histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction and confirmed dMMR or MSI-H
•Preoperative CT or MRI staging meeting the following criteria: T2 and above, with or without lymph node involvement, without clear distant metastasis
•ECOG score of 0-
•Expected survival ≥ 2 years.
•Good organ function (no blood transfusion, no hematopoietic stimulating factor, no albumin or blood product transfusion within 14 days prior to the examination).
•Platelet (PLT) count ≥ 90\*109/L.
•Neutrophil count (ANC) ≥ 1.5\*109/L.
•Hemoglobin (Hb) level ≥ 9.0 g/dl.
•International normalized ratio (INR) ≤ 1.

Exclusion Criteria

•Previously received chemotherapy, radiotherapy or immunotherapy for gastric cancer
•Previously diagnosed any other malignancy with a primary site or histological type different from gastric cancer within 5 years prior to study entry, except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
•With known hypersensitivity to the study drug or excipients, or to similar drugs
•Received major surgery or open biopsy, or had a major trauma within 4 weeks prior to the start of study treatment
•Received immunosuppressive drugs (excluding inhaled corticosteroids or ≤10 mg/day prednisone or equivalent pharmacophysiologic doses of other systemic steroids) within 2 weeks prior to the start of study treatment
•Planned live attenuated vaccination within 4 weeks prior to the start of study treatment or during the study period
•Inability to discontinue CYP3A4 inducers or inhibitors within 1 week prior to the start of study treatment and during the study period
•Presence of any autoimmune disease or history of autoimmune disease.
•Human immunodeficiency virus (HIV) infection (HIV antibody positive), or active hepatitis C virus (HCV) infection (HCV antibody positive), or active hepatitis B virus (HBV) infection (HBsAg positive and HBV-DNA ≥ 2000 IU/ml copies/ml)), or other serious infection requiring antibiotics for systemic therapy, or during screening/study Unexplained temperature \>38.5°C prior to the start of treatment.
•Presence of the following diseases within 6 months prior to the start of study treatment: myocardial infarction, severe/unstable angina, NYHA class 2 or higher congestive heart failure, poorly controlled arrhythmias, etc.