A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Ther… (NCT07438106) | Clinical Trial Compass
RecruitingPhase 2
A Phase II Study of HRS-4642 Combined With AG (Nab-paclitaxel and Gemcitabine) as Conversion Therapy for Locally Advanced Pancreatic Cancer
China30 participantsStarted 2026-01-28
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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°.
. Pancreatic body/tail tumors: Tumor contact with the SMA or celiac artery \>180°; or contact with the celiac artery with aortic invasion; or tumor invasion of the jejunal branches of the SMA.
. Inability to safely reconstruct the portal vein-superior mesenteric vein due to tumor invasion, venous occlusion, or extensive involvement of the jejunal branches of the superior mesenteric vein.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the efficacy of HRS-4642 combined with AG (nab-paclitaxel and gemcitabine) as conversion therapy in patients with locally advanced pancreatic cancer, as measured by the Objective Response Rate (ORR).
Timeframe: every 6 weeks(±7 days) from the first dose of study treatment until disease progression, initiation of new anti-cancer therapy, withdrawal of consent, death, or study termination, whichever occurs first, assessed up to 24 months
Trial details
NCT IDNCT07438106
SponsorThe First Affiliated Hospital with Nanjing Medical University
. KRAS G12D mutation confirmed by tissue histology or peripheral blood testing.
Exclusion 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.
. History of allergy or hypersensitivity considered clinically significant by the investigator.
. Presence of clinically significant acute or chronic pancreatitis.
. History of drug abuse, chronic alcoholism, or infectious diseases such as AIDS (i.e., HIV-1/2 antibody positive).