NCT07438106
A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer
Recruiting · Phase 2 · The First Affiliated Hospital with Nanjing Medical University · registry updated 2026-08-12
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
This study will evaluate the effectiveness and safety of HRS-4642 in combination with nab-paclitaxel and gemcitabine (AG regimen) as conversion therapy for patients with locally advanced pancreatic cancer. Participants will undergo regular assessments, including imaging scans and CA19-9 biomarker tests. If disease recurrence is suspected, unscheduled evaluations may be performed. For participants who discontinue treatment due to reasons other than disease progression (e.g., toxicity), tumor assessments will continue as scheduled until progression, loss to follow-up, death, consent withdrawal, or study termination. After the final treatment, participants will enter a survival follow-up phase. Investigators will contact the participants or their families approximately every month (±7 days) to collect information on survival status (date and cause of death) and any subsequent anti-cancer treatments until death, loss to follow-up, study termination, or other study endpoints are met. All follow-up information will be documented in the medical records.
Inclusion
- Participants must meet all of the following criteria to be eligible for this study:
- Age ≥18 years and ≤75 years, regardless of gender.
- Histologically or cytologically confirmed pancreatic ductal adenocarcinoma.
- Radiologically confirmed locally advanced disease, defined as:
- No distant metastasis.
- Pancreatic head/uncinate process tumors: Tumor contact with the superior mesenteric artery (SMA) \>180°.
Exclusion
- Participants will be excluded from the study if they meet any of the following criteria:
- Presence of portal hypertension or cavernous transformation of the portal vein; tumor involvement of the gastrointestinal tract causing gastrointestinal bleeding; tumor leading to intra-abdominal fistula or abscess; tumor encasement of the celiac artery or superior mesenteric artery (SMA) with significant vascular wall involvement (moth-eaten appearance).
- Diagnosis of malignancies other than pancreatic cancer within 5 years prior to the first dose (excluding radically treated skin basal cell carcinoma, squamous cell carcinoma, and/or carcinoma in situ).
- History of active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic therapy.
- Current use of systemic corticosteroid therapy (excluding topical, inhaled, nasal, or intra-articular corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first study dose. Note: Use of physiologic doses of corticosteroids (≤10 mg/day prednisone or equivalent) is permitted.
- Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.