To hear about similar clinical trials, please enter your email below
Trial Title:
Disitamab Vedotin Combined With Sintilimab as First-line Treatment of Elderly Patients With Gastric Cancer
NCT ID:
NCT05720533
Condition:
Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Disitamab vedotin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Disitamab Vedotin Combined With Sintilimab
Description:
Disitamab Vedotin injection：2.5mg/kg，IV，Q3W Sintilimab injection：200mg，IV, Q3W
Arm group label:
Disitamab Vedotin Combined With Sintilimab
Other name:
Combined treatment group
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.
Detailed description:
The primary objective of this study was to explore the safety and median PFS of Disitamab
vedotin combined with Sintilimab as first-line treatment in elderly patients with HER2
overexpression Gastric Cancer.The secondary objective of this study was to evaluate the
ORR, DCR, DOR and OS of Disitamab vedotin combined with Sintilimab as first-line
treatment in elderly patients with HER2 overexpression Gastric Cancer.To provide a better
treatment plan for elderly patients with Gastric Cancer.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 1, 2023
Completion date:
March 1, 2025
Lead sponsor:
Agency:
Tianjin Medical University Cancer Institute and Hospital
Agency class:
Other
Source:
Tianjin Medical University Cancer Institute and Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05720533
