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New treatment option for Gastric Cancer
Official title Disitamab Vedotin Combined With Tislelizumab and Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Cancer With HER2 Overexpression
ClinicalTrials.gov ID: NCT06560528
What this study is testing
What is combination with Disitamab Vedotin and with Tislelizumab and Capecitabine?
combination with Disitamab Vedotin and with Tislelizumab and Capecitabine is an investigational medicine, being studied as a potential treatment for gastric cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The efficacy and safety of combination with Disitamab Vedotin and with Tislelizumab and Capecitabine for perioperative treatment of locally advanced gastric cancer with HER2 overexpression.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 1) Volunteer to take part in the study ;
- 2) Age 18\~75 (including 75), male or female;
- 3) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
- 4) Clinical stage Ⅱ, Ⅲ (cT2-4a ,N+ or -, M0, AJCC 8th);
- 5) Have not received systematic treatment;
You likely can't join if
- 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...
- 2) Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic...
- 3) Have received allogeneic stem cells or solid organ transplantation in the past;
- 4) Patients who have received other anti-tumor systemic therapy in the past (including traditional Chinese medicine with anti-tumor indications), and...
See the full eligibility criteria
- 1) Volunteer to take part in the study ;
- 2) Age 18\~75 (including 75), male or female;
- 3) Gastric cancer or adenocarcinoma of gastroesophageal junction confirmed by histology and/or cytology;
- 4) Clinical stage Ⅱ, Ⅲ (cT2-4a ,N+ or -, M0, AJCC 8th);
- 5) Have not received systematic treatment;
- 6) 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;
- 7) At least one assessable lesion (RECIST 1.1 );
- 8) Expected survival time ≥ 6 months;
- 9) ECOG 0-1;
- 10) Major organs are functioning normally；
- 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) Suffering from diseases that affect the absorption, distribution, metabolism or clearance of the study drug (such as severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorder, etc.);
- 3) Have received allogeneic stem cells or solid organ transplantation in the past;
- 4) 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...
- 5) Previous or current congenital or acquired immunodeficiency disease;
- 6) Active or previously recorded autoimmune diseases or inflammatory diseases (including but not limited to: autoimmune hepatitis, interstitial pneumonia, inflammatory bowel disease, systemic lupus erythematosus...
- 7) Systemic immunosuppressive drugs were used within 2 weeks before enrollment, or were expected to be required during the study, except for the following:
- Corticosteroids for intranasal, inhalation, external or local injection (such as intra-articular injection);
- The dose of prednisone or other equivalent systemic corticosteroids does not exceed 10 mg/day;
- Preventive use of corticosteroids for hypersensitivity;
- 8) Allergic to the study drug;
- 9) Thrombosis or thromboembolism events occurred in the past 6 months, such as stroke and/or transient ischemic attack, deep vein thrombosis, pulmonary embolism, etc;
- 10) Patients at risk for severe bleeding；
- 11) Cardiovascular diseases with significant clinical significance;
- 12) Other significant clinical and laboratory abnormalities, which the researchers think affect the safety evaluation;
- 13) Serious infection in active period or poorly controlled clinically;
- 14) Not recovered from the operation;
- 15) Pregnant or lactating women, and women or men with fertility who are unwilling or unable to take effective contraceptive measures;
- 16) Other situations that the investigator thinks are not suitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.