Malignancies of the gastrointestinal tract comprise colorectal carcinoma, gastric cancer, and biliary tract neoplasms.
Conditions
Interventions
Cohort A: Histologically confirmed advanced (unresectable locally advanced or metastatic) HER2-overexpressing or HER2-amplified adenocarcinoma of the stomach or gastroesophageal junction:Pertuzumab In
Cohort B: Histologically confirmed advanced (unresectable locally advanced or metastatic) colorectal cancer with HER2 overexpression or amplification and wild-type RAS gene:Cetuximab-beta: Intravenous
Cohort C: Biliary tumors that are histologically confirmed as being in the advanced stage (unresectable locally advanced or metastatic) and showing HER2 overexpression or amplification:Disitamab vedot
administered every 3 weeks as one treatment cycle, until disease progression or unmanageable toxicity.
Lenvatinib mesylate: Recommended dose is 8 mg once daily (qd) orally for patients weighing <60 k
12 mg qd orally for patients weighing =60 kg. Continuous administration until disease progression or occurrence of unmanageable toxicity.
Sponsors
The First Affiliated Hospital of Henan University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Participants voluntarily enrolled and signed the informed consent form, with expected good compliance and willingness to participate in follow-up. 2. Age >= 18 years and = 90 g/L; 2) Absolute neutrophil count (NEUT) >= 1.5×10^9/L; 3) Platelet count (PLT) >= 100×10^9/L; 4) White blood cell count >= 2.5×10^9/L; (2) Biochemical laboratory criteria: 1) Total bilirubin (TBIL) = 50 mL/min (calculated using the Cockcroft-Gault formula); (3) Coagulation function criteria: Prothrombin time (PT), activated partial thromboplastin time (APTT), and international normalized ratio (INR) = 50%; 2) 12-lead electrocardiogram: QT interval for females < 470 ms.
Exclusion criteria
Exclusion criteria: 1. Allergy to any trial drug or its excipients, or a history of severe allergies, or contraindication to the trial drug. 2. Poorly controlled cardiovascular events, including: (1) NYHA >= II heart failure; (2) Unstable angina; (3) Myocardial infarction within the past year; (4) Clinically significant supraventricular or ventricular arrhythmias requiring pharmacological treatment or intervention; (5) Cerebral hemorrhage or infarction (excluding asymptomatic lacunar infarcts requiring no treatment); (6) Severe cardiovascular events within the past 12 months; (7) Uncontrolled hypertension, defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg despite monotherapy; (8) History of arterial thrombosis or deep vein thrombosis within the past 6 months, or evidence of bleeding tendency within the past 2 months (regardless of severity); (9) Stroke or transient ischemic attack within the past 12 months. 3. Systemic administration of traditional Chinese medicine or immunomodulatory drugs with indications for gastric cancer, biliary tract tumors, or colorectal cancer within 2 weeks prior to first dose, including thymosin, interferon, interleukin, etc., except for local use for ascites control. 4. History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or poorly controlled systemic diseases (including but not limited to diabetes, hypertension, etc.). 5. History of active immunodeficiency or autoimmune disease, including HIV positivity, or other acquired or congenital immunodeficiency disorders, organ transplantation history, or autoimmune disease. 6. Severe chronic or active infections requiring systemic antimicrobial, antifungal, or antiviral therapy, including tuberculosis; exclusion of patients with a history of active tuberculosis infection >= 1 year prior to screening unless proof of completed standard treatment is provided. 7. Presence of brain metastases or leptomeningeal metastases. 8. Clinically significant pleural effusion, pericardial effusion, or ascites requiring multiple drainage procedures within 2 weeks prior to first dose of study drug. 9. Clinically detectable second primary malignancy at enrollment, or history of other malignancies within the past 5 years (excluding adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ). 10. Major surgery within <= 28 days prior to first dose of study drug. 11. History of allogeneic stem cell transplantation or organ transplantation. 12. Current gastrointestinal conditions such as duodenal ulcer, ulcerative colitis, or bowel obstruction, or other conditions deemed by the investigator to potentially cause gastrointestinal bleeding or perforation; or history of intestinal perforation or fistula with incomplete healing after surgical treatment. 13. Administration of live vaccines within 4 weeks (inclusive) prior to first dose of study drug; seasonal influenza vaccines (typically inactivated) are permitted; intranasal vaccines (live) are prohibited. 14. Other factors deemed by the investigator that may lead to premature termination of the study, such as other severe diseases (including psychological or psychiatric disorders) requiring concurrent treatment, significant laboratory abnormalities, or family/social factors affecting subject safety or data/sample collection. 15. Currently participating in interventional clinical trials, or receiving other investigational dr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Objective response rate;Duration of response;Disease control rate;Adverse Event and Serious Adverse Event; | — |
Countries
China
Contacts
Public ContactWang Tao
The First Affiliated Hospital of Henan University of Chinese Medicine
Outcome results
None listed