Disitamab Vedotin Combined With Sintilimab as First-line Treatment of Elderly Patients With Gastric Cancer

NCT05720533 | Unknown Phase 2

• 1 other identifier: E20221383
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to explore the safety and efficacy of Disitamab vedotin combined with Sintilimab in elderly patients with HER2 overexpression Gastric Cancer. This is a single-arm exploratory clinical study. 20 patients with eHER2 overexpression gastric cancer are scheduled to be enrolled. Treatment regimen is Disitamab vedotin 2.5mg/kg and Sintilimab 200mg every 21 days, until disease progression or intolerable adverse reactions or death.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• PFS (Progression-Free-Survival)

  The time from randomization to tumor progression or death.The efficacy of this study was determined according to Recist version 1.1 criteria.

  24 months

Secondary Outcomes (5)

• ORR（Objective Response Rate）

  24 months

• DCR（Disease control rate）

  24 months

• DOR（Duration of response）

  24 months

• OS (Overall survival time)

  24 months

• The Adverse Events

  24 months

Study Arms (1)

Disitamab Vedotin Combined With Sintilimab

EXPERIMENTAL

Treatment regimen is Disitamab vedotin 2.5mg/kg and Sintilimab 200mg every 21 days, until disease progression or intolerable adverse reactions or death.

Drug: Disitamab Vedotin Combined With Sintilimab

Interventions

Disitamab Vedotin Combined With Sintilimab DRUG

Disitamab Vedotin injection：2.5mg/kg，IV，Q3W Sintilimab injection：200mg，IV, Q3W

Also known as: Combined treatment group

Disitamab Vedotin Combined With Sintilimab

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \) Volunteer to take part in the study ;
• \) Age ≥65 , male or female;
• \) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
• \) Have not received systematic treatment; If the subject has received adjuvant therapy after completing radical treatment for early gastric cancer and the subject has relapsed disease, ensure that the end of adjuvant therapy is more than 6 months from the first dose of the study and that various toxicities due to the adjuvant therapy have recovered.
• \) The HER2 immunohistochemistry (IHC) test result is IHC 3+or 2+, and the previous test results of the subject (confirmed by the investigator) are acceptable;
• \) At least one assessable lesion (RECIST 1.1 );
• \) Expected survival time ≥ 6 months;
• \) ECOG 0-2;
• \) If the main organs function normally, they meet the following standards:
• Blood routine examination (no blood transfusion and G-CSF use within 14 days before screening):
• Hemoglobin ≥ 90 g/L;
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L；
• White blood cell count ≥ 3.0 × 109/L；
• Platelet count ≥ 80 × 109/L；
• Blood biochemical examination (albumin was not used within 14 days before screening):

You may not qualify if:

• \) Have a history of malignant tumors other than gastric cancer, except for the following two cases:
• The patient has received possible curative treatment and there is no evidence of the disease within 5 years;
• The resected skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ and other carcinoma in situ were successfully received;
• \) Have received allogeneic stem cells or solid organ transplantation in the past;
• \) Patients who have received other anti-tumor systemic therapy in the past (including traditional Chinese medicine with anti-tumor indications), and have been less than 4 weeks from the completion of treatment to the administration of this study, or the adverse events caused by previous treatment have not recovered to ≤ CTCAE level 1 (except hair loss and pigmentation);
• \) Previous or current congenital or acquired immunodeficiency disease;
• \) Allergic to the study drug;
• \) Other significant clinical and laboratory abnormalities, which the researchers think affect the safety evaluation;
• \) Serious infection in active period or poorly controlled clinically;
• \) Not recovered from the operation;
• \) Pregnant or lactating women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Zhansheng Jiang, Doctor

CONTACT

13512035574; zhjiang@tmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2023
• First Posted: February 9, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: March 1, 2025
• Last Updated: February 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share