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:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT07176702
Eligibility Criteria:
Inclusion Criteria:
* Voluntary Participation Willingly participate in the clinical study; fully comprehend the study details and sign the Informed Consent Form (ICF); commit to and demonstrate capacity to complete all trial procedures.
* Age and Gender Any gender; age ≥18 and ≤75 years at the time of ICF signing.
* Diagnosis Histologically or cytologically confirmed metastatic pancreatic ductal adenocarcinoma (PDAC).
* Prior Therapy \*No prior systemic antitumor therapy for metastatic PDAC.
\*Exception: Patients who received one cycle of chemotherapy (nab-paclitaxel + gemcitabine) as initial treatment for newly diagnosed PDAC may enroll.
\*Prior neoadjuvant/adjuvant therapy is permitted if completed \>6 months before enrollment, and treatment-related adverse events (AEs) have recovered to NCI-CTCAE ≤ Grade 1 (alopecia excluded).
* Measurable Disease At least one measurable lesion per RECIST v1.1, assessed by the investigator. Target lesions must not be exclusively bone metastases.
* HER2 Status \*HER2-positive defined by ASCO/CAP gastric cancer HER2 testing guidelines: IHC 3+ (primary or metastatic lesion), or IHC 2+ with ISH/FISH-positive confirmation.
\*Note: ≤15 patients with IHC 2+/FISH-positive status may enroll.
* Performance Status ECOG performance status 0 or 1 within 7 days prior to first dose.
* Life Expectancy Expected survival ≥3 months.
* Hepatitis B \*HBsAg-negative and HBcAb-negative. \*If HBsAg-positive or HBcAb-positive, HBV-DNA must be \<2500 copies/mL or 500 IU/mL (or within institutional normal range).
* Hepatitis C \*HCV antibody-negative.
* If HCV antibody-positive, HCV-RNA must be negative.
* Exclusion: Co-infection of HBV and HCV (HBsAg/HBcAb-positive and HCV antibody-positive).
* HIV Status HIV antibody-negative.
* Organ Function
Adequate organ function within 14 days before first dose (without transfusion, albumin, thrombopoietin, or CSF support):
\*Hematology: Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L Platelets ≥100 × 10⁹/L Hemoglobin ≥90 g/L
\*Liver: Total bilirubin ≤1.5 × ULN AST/ALT ≤2.5 × ULN (≤5 × ULN if liver metastases present) Alkaline phosphatase ≤5.0 × ULN Albumin ≥25 g/L
\*Renal: Creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)
\*Coagulation: INR ≤1.5 × ULN APTT ≤1.5 × ULN PT ≤1.5 × ULN
* Contraception
* Females of childbearing potential: Negative serum pregnancy test within 7 days before first dose.
* All participants: Use of ≥1 medically approved contraceptive method (e.g., IUD, oral contraceptives, barrier devices) during treatment and for ≥7 months after last dose.
Exclusion Criteria:
* Other Malignancies
History of other malignancies within 2 years prior to first dose, except:
Curatively treated localized tumors (e.g., basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate/cervix/breast/thyroid).
* Prior Anthracycline Exposure
Cumulative doxorubicin dose \> 360 mg/m² (or equivalent):
Equivalent agents: Epirubicin \>720 mg/m², mitoxantrone \>120 mg/m², idarubicin \>90 mg/m², or liposomal doxorubicin \>360 mg/m² doxorubicin-equivalent.
If multiple anthracyclines were used, the total cumulative dose must not exceed 360 mg/m² doxorubicin-equivalent.
* Prior HER2-Targeted Therapy Any previous HER2-targeted treatment (e.g., trastuzumab, pertuzumab).
* Active Gastrointestinal Bleeding
≥ Grade 2 toxicity per NCI-CTCAE v5.0.
* CNS Involvement Central nervous system (CNS) metastases and/or leptomeningeal metastases.
* Cardiovascular Events
History within 6 months prior to first dose:
Cerebrovascular accident, myocardial infarction, unstable angina, or poorly controlled arrhythmias.
QTc interval ≥450 ms (males) or ≥470 ms (females) (Fridericia formula).
* Cardiac Dysfunction NYHA Class III-IV heart failure or left ventricular ejection fraction (LVEF) \< 55% by echocardiography.
* Pulmonary/Infectious Conditions Interstitial lung disease (current or history). Active infection requiring systemic therapy or active tuberculosis.
* Recent Live Vaccines Administration of live attenuated vaccines within 28 days prior to first dose (exception: inactivated influenza or COVID-19 vaccines).
* Major Surgery Within 28 days prior to first dose.
* Radiotherapy Curative radiotherapy within 28 days prior to first dose.
* Concurrent Clinical Trials Current participation in other interventional studies or use of investigational drugs/devices within 28 days prior to first dose.
* Hypersensitivity Known severe allergy to monoclonal antibodies or excipients of the study drugs.
* Substance Abuse History of illicit drug use or psychiatric medication abuse.
* Pregnancy/Lactation Pregnant or breastfeeding women.
* Other Exclusionary Factors
Any condition deemed by the investigator to:
Compromise patient safety or data integrity. Require concomitant treatment for severe comorbidities (including psychiatric disorders).
Exhibit critically abnormal laboratory values. Pose significant social/familial impediments to study completion.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07176702
Study Brief:
Protocol Section:
NCT07176702