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New treatment option for Gastric Cancer
Official title Perioperative Disitamab Vedotin Plus Toripalimab and XELOX in Gastric or Gastroesophageal Junction Adenocarcinoma.
ClinicalTrials.gov ID: NCT06155383
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as a pill taken by mouth, 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 purpose of this study is to evaluate the efficacy and safety of perioperative Disitamab Vedotin plus Toripalimab and XELOX versus Disitamab Vedotin plus Toripalimab versus XELOX in subjects with HER2-expressing resectable locally advanced gastric or gastroesophageal junction adenocarcinoma.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Voluntarily participate and sign the informed consent form;
- Male or female, ≥18 years;
- Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology;
- Clinical stage cT3-4aN+, no distant metastasis (M0);
- According to the baseline imaging and medical history data evaluated by the Investigators, radical surgery for gastric cancer and R0 resection is...
You likely can't join if
- Received any anti-tumor therapy for gastric or gastroesophageal junction adenocarcinoma before study dosing, including chemotherapy, radiotherapy...
- The investigators considered perioperative period treatment of patients requiring radiotherapy for target lesions；
- Major surgery was performed within 4 weeks before the start of study dosing and did not fully recover;
- Patients with active gastrointestinal bleeding or high risk of bleeding within 2 weeks prior to screening;
- Gastrointestinal perforation/fistula 6 months before screening;
- Upper digestive tract obstruction that cannot guarantee drug absorption, functional abnormalities or malabsorption syndrome, which can affect the...
See the full eligibility criteria
Who can join
- Voluntarily participate and sign the informed consent form;
- Male or female, ≥18 years;
- Patients with gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology;
- Clinical stage cT3-4aN+, no distant metastasis (M0);
- According to the baseline imaging and medical history data evaluated by the Investigators, radical surgery for gastric cancer and R0 resection is expected; people had not previously received any antitumor therapy for...
- HER2- expression: IHC 1+, 2+, 3+;
- ECOG performance status score of 0 or 1;
- Cardiac function: left ventricular ejection fraction ≥50%;
- The following criteria should be met within 7 days prior to study dosing (normal values are based on the clinical trial center): 9.1Bone marrow function:
- absolute neutrophil count (ANC) ≥1.5×109/L (no treatment with granulocyte colony-stimulating factor within 1 week prior to examination);
- Platelets ≥100×109/L (platelets should not be transfused within 1 week before the examination, and recombinant human thrombopoietin therapy should not be used within 2 weeks)
- hemoglobin ≥9g/dL (blood transfusion and erythropoietin treatment are not allowed within 2 weeks prior to the examination); 9.2Liver function:
- Serum total bilirubin ≤1.5 times the upper limit of normal (ULN);
- alanine amino transferase (ALT) and aspartate amino transferase (AST) ≤2.5 × ULN; 9.3 Kidney function: a.Blood creatinine ≤1.5×ULN or creatinine clearance (CrCl) ≥50 mL/min according to Cockcroft-Gault formula method...
- prothrombin time (PT) ≤1.5×ULN;
- thrombin time (TT) ≤ 1.5×ULN;
- activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
- Female people should be surgically sterilized, postmenopausal, or agree to use at least one medically acceptable method of contraception (e.g., intrauterine device, contraceptives, or condoms) for 7 days before the...
- Able to understand trial requirements, willing and able to follow trial and follow-up procedures.
What rules you out
- Received any anti-tumor therapy for gastric or gastroesophageal junction adenocarcinoma before study dosing, including chemotherapy, radiotherapy, targeted therapy, immunotherapy and other anti-tumor drug therapy...
- The investigators considered perioperative period treatment of patients requiring radiotherapy for target lesions；
- Major surgery was performed within 4 weeks before the start of study dosing and did not fully recover;
- Patients with active gastrointestinal bleeding or high risk of bleeding within 2 weeks prior to screening;
- Gastrointestinal perforation/fistula 6 months before screening;
- Upper digestive tract obstruction that cannot guarantee drug absorption, functional abnormalities or malabsorption syndrome, which can affect the absorption of capecitabine ;
- Peripheral polyneuropathy ≥ NCI Ⅱ grade；
- Serum virology examination (based on the normal value of the research center):
- Positive HBsAg test with positive HBV DNA copy number;
- Positive HCVAb test with positive HCV RNA PCR test.
- Positive HIVAb test.
- Have received live vaccine within 4 weeks prior to screening or plan to receive any vaccine during the study period (except for the novel coronavirus vaccine);
- Heart failure rated 3 or higher by the New York College of Cardiology (NYHA);
- Cardiac chest pain, defined as moderate pain that restricts daily activities, occurred within 28 days prior to screening. There were serious arteriovenous thrombosis events or cardiovascular and cerebrovascular...
- There is an active or advanced infection that requires systematic treatment (experimental medication may be initiated 2 weeks after the end of anti-infective therapy), such as active tuberculosis;
- There are systemic diseases that have not been stably controlled which are determined by investigators, including diabetes, hypertension, cirrhosis, etc.;
- A history of lung disease that requires treatment and has the potential to interfere with surgery, including but not limited to interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, and acute lung...
- Active autoimmune diseases requiring systemic therapy (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressive drugs) within 2 years prior to dose administration, and replacement therapies...
- Other malignancies within 5 years prior to screening, other than those that have been cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous...
- Previously received allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- Allergies to any of the drugs in this study;
- Known deficiency of dipyrimidine dehydrogenase (DPD);
- Receiving immunotherapy (including but not limited to interleukin, interferon, thymus hormone) or other investigational drugs within 28 days prior to screening;
- Pregnant or lactating women;
- Any other disease, metabolic disorder, or abnormal findings upon physical examination or laboratory examination that makes the subject unsuitable for receiving the investigational drug, affects the interpretation of...
- Subject is assessed to be unable or unwilling to comply with the requirements of the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Fuzhou, Fujian, China
- Kunming, Fujian, China
- Xiamen, Fujian, China
- Wuwei, Gansu, China
- Guangzhou, Guangdong, China
- Harbin, Heilongjiang, China
- Zhengzhou, Henan, China
- Jinan, Shangdong, China
- Chengdu, Sichuan, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Fuzhou, Fujian, China; Kunming, Fujian, China; Xiamen, Fujian, China; Wuwei, Gansu, China; Guangzhou, Guangdong, China and 4 more location(s). 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.