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

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Criteria

Inclusion Criteria:

• 1) Volunteer to take part in the study ;

• 2) Age ≥65 , male or female;

• 3) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;

• 4) 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.

• 5) 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;

• 6) At least one assessable lesion (RECIST 1.1 );

• 7) Expected survival time ≥ 6 months;

• 8) ECOG 0-2;

• 9) 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):

1. Hemoglobin ≥ 90 g/L;

2. Absolute neutrophil count (ANC) ≥ 1.5 × 109/L；

3. White blood cell count ≥ 3.0 × 109/L；

4. Platelet count ≥ 80 × 109/L；

Blood biochemical examination (albumin was not used within 14 days before screening):

5. Albumin ≥ 28 g/L;

6. Total bilirubin ≤ 2 × Upper limit of normal value (ULN);

7. In the absence of liver metastasis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤ 2.5 × ULN； ALT, AST and ALP ≤ 5× ULN in case of liver metastasis ；

8. Alkaline phosphatase (ALP) ≤ 5 × ULN；

9. Creatinine ≤ 1.5 × ULN； Or the creatinine clearance rate (CrCl) calculated by Cockcroft Gault formula is ≥ 50 mL/min;

Coagulation function:

10. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN；

j) Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN。

Exclusion Criteria:

• 1) Have a history of malignant tumors other than gastric cancer, except for the following two cases:

1. The patient has received possible curative treatment and there is no evidence of the disease within 5 years;

2. 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;

• 2) Have received allogeneic stem cells or solid organ transplantation in the past;

• 3) 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);

• 4) Previous or current congenital or acquired immunodeficiency disease;

• 5) Allergic to the study drug;

• 6) Other significant clinical and laboratory abnormalities, which the researchers think affect the safety evaluation;

• 7) Serious infection in active period or poorly controlled clinically;

• 8) Not recovered from the operation;

• 9) Pregnant or lactating women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;

• 10) Other situations that the investigator thinks are not suitable for inclusion.