Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT07053150
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Patients with unresectable locally advanced T3-4 stage or M1 stage metastatic digestive system tumors confirmed by histology or cytology, including gastric cancer, colorectal cancer, hepatocellular carcinoma, biliary tract cancer and pancreatic cancer
* Patients who have not received systematic treatment in the past or whose disease has progressed or is intolerant after standard first-line treatment, and whose disease has progressed for more than 6 months after neoadjuvant therapy/whose last adjuvant therapy failed/who have completed (new) adjuvant therapy for less than 6 months from disease recurrence can be enrolled
* Histologically or cytologically confirmed HER2-positive (IHC 3+ or IHC 2+/FISH-amplified/NGS-confirmed) locally advanced or metastatic digestive system tumors (including gastric, colorectal, hepatocellular, biliary tract cancers)
* ECOG performance status 0-2
* At least one measurable lesion per RECIST 1.1 criteria
* Adequate organ function:
* Hematologic: ANC ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥9 g/dL
* Hepatic: Total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤5×ULN for liver metastases/HCC); albumin ≥28 g/L
* Renal: Serum creatinine ≤1.5×ULN or CrCl ≥50 mL/min; urine protein \<2+ (if ≥2+, 24-hour urine protein \<1 g)
* Coagulation: INR ≤2.3 or PT prolongation ≤6 seconds
* Life expectancy ≥12 weeks
* Fertile patients must use effective contraception during treatment and for 6 months after last dose
* Willing and able to provide written informed consent
Exclusion Criteria:
* Previous treatment with any HER2-targeted therapy (e.g., trastuzumab)
* History of hematologic malignancies
* Pregnancy, lactation, or plans to become pregnant during study
* Last anticancer therapy ≤28 days prior to enrollment or unresolved toxicities from prior therapy
* Contraindications to immunotherapy including:
* History of organ transplantation
* Severe autoimmune diseases
* Grade ≥4 immune-related adverse events from prior immunotherapy
* Uncontrolled active infections
* Use of systemic immunosuppressants (\>10 mg/day prednisone equivalent) within 14 days
* Known hypersensitivity to PD-1 inhibitors, pyrotinib, or monoclonal antibodies
* Participation in other clinical trials within 3 months
* Symptomatic ascites, pleural or pericardial effusion requiring drainage
* Life-threatening bleeding events within 3 months or arterial/venous thrombosis within 6 months (except stable catheter-related thrombosis)
* History of pulmonary fibrosis, interstitial lung disease, or drug-related pneumonitis
* Active tuberculosis requiring treatment or treated within past year
* Major surgery within 4 weeks or unhealed surgical wounds
* Severe dysfunction of major organs (heart, lungs, liver, kidneys, CNS)
* Any other condition that may increase risk or interfere with study results as judged by investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07053150
Study Brief:
Protocol Section:
NCT07053150