- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05720533
Disitamab Vedotin Combined With Sintilimab as First-line Treatment of Elderly Patients With Gastric Cancer
Safety and Efficacy of Disitamab Vedotin Combined With Sintilimab as First-line Treatment of Elderly Patients With HER2 Overexpression Gastric Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Zhansheng Jiang, Doctor
- Phone Number: 13512035574
- Email: zhjiang@tmu.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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):
- 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):
- Albumin ≥ 28 g/L;
- Total bilirubin ≤ 2 × Upper limit of normal value (ULN);
- 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 ;
- Alkaline phosphatase (ALP) ≤ 5 × ULN;
Creatinine ≤ 1.5 × ULN; Or the creatinine clearance rate (CrCl) calculated by Cockcroft Gault formula is ≥ 50 mL/min;
Coagulation function:
- 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:
- 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;
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Disitamab Vedotin Combined With Sintilimab
Treatment regimen is Disitamab vedotin 2.5mg/kg and Sintilimab 200mg every 21 days, until disease progression or intolerable adverse reactions or death.
|
Disitamab Vedotin injection:2.5mg/kg,IV,Q3W
Sintilimab injection:200mg,IV, Q3W
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS (Progression-Free-Survival)
Time Frame: 24 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ORR(Objective Response Rate)
Time Frame: 24 months
|
The rate of participants that achieve either a complete response (CR) or a partial response (PR).
|
24 months
|
DCR(Disease control rate)
Time Frame: 24 months
|
The percentage of cases with remission (PR + CR) and stable lesions (SD) after treatment was assessable.
|
24 months
|
DOR(Duration of response)
Time Frame: 24 months
|
DoR was defined as the time from the date of first documented response until the first date of documented progression or death in the absence of disease progression.
The time of the initial response was defined as the latest of the dates contributing toward the first visit response of CR or PR.
If a patient did not progress following a response, then their DoR was censored at the PFS censoring time.
|
24 months
|
OS (Overall survival time)
Time Frame: 24 months
|
The time of death from all causes for all patients from the date of randomization.
|
24 months
|
The Adverse Events
Time Frame: 24 months
|
AEs are any adverse medical events that occur in a subject or clinical subject and is not necessarily causally related to the treatment.
Safety assessment in this study was conducted by the investigator in accordance with the definition of CTCAE 5.0.
|
24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E20221383
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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