HRS-4642 added to chemotherapy around surgery for pancreatic cancer
Tests HRS-4642 plus chemotherapy in adults with operable or borderline operable pancreatic cancer.
Plain-language title generated from the registry record
Registry title: HRS-4642 Combined With Antitumor Agents for the Treatment of Perioperative Pancreatic Cancer
Key facts
- Where
- Beijing and Shanghai, ChinaSee the 2 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07900789, who can take part
Where in China
- Peking Union Medical College Hospital, Chinese Academy of Medical SciencesBeijing, ChinaNo longer taking part
- Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Trial code
- NCT07900789
- Record updated
- 28 October 2026
- Original description
The study is being conducted To evaluate the efficacy of HRS-4642 in combination with gemcitabine plus nab-paclitaxel (AG) (± SHR-1316) versus standard therapy in participants, high-risk resectable/borderline resectable pancreatic cancer (HR-RPC/BRPC), based on Event-Free Survival (EFS).Read full original descriptionShow less
A Randomized, Controlled, Open-Label, Multicenter Phase III Clinical Study of HRS-4642 in Combination With Other Antitumor Agents Versus Standard Therapy in the Perioperative Treatment of Pancreatic Cancer
The study is being conducted To evaluate the efficacy of HRS-4642 in combination with gemcitabine plus nab-paclitaxel (AG) (± SHR-1316) versus standard therapy in participants, high-risk resectable/borderline resectable pancreatic cancer (HR-RPC/BRPC), based on Event-Free Survival (EFS).
Inclusion: Able to provide informed consent, with a signed and dated IRB/EC-approved informed consent form (ICF), and willing and able to comply with the scheduled visits, treatment plan, examinations, and other protocol-required procedures; Aged between 18 and 75 years (inclusive) at the time of ICF signing; of either gender; Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1; Expected survival of at least 6 months; Histologically or cytologically confirmed pancreatic cancer originating from the pancreatic ductal epithelium; High-risk resectable pancreatic cancer (HR-RPC) or borderline resectable pancreatic cancer (BRPC); At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1; Adequate major organ function meeting the protocol-specified criteria.-.
Exclusion: Prior systemic therapy for pancreatic cancer, including neoadjuvant chemotherapy or radiotherapy; Has not recovered from the toxicity and/or complications of prior interventions to NCI-CTCAE Grade ≤ 1 or the level specified in the inclusion/exclusion criteria; Received systemic immunosuppressive therapy within 14 days prior to randomization; Known or suspected interstitial lung disease; or presence within 6 months prior to randomization of moderate-to-severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity or significantly impair respiratory function; Gastrointestinal obstruction within 6 months prior to initiation of study treatment, or current signs and symptoms of gastrointestinal obstruction; Clinically significant bleeding episodes or a clear bleeding tendency within 6 months prior to randomization; Uncontrolled or severe cardiovascular/cerebrovascular disease, or arterial/venous thromboembolic events within 6 months prior to randomization; or arrhythmia, deep vein thrombosis, etc. requiring clinical intervention; Diagnosis of any other malignancy within 5 years prior to randomization; Serious infection within 28 days prior to the first dose; or active infection requiring therapeutic intravenous antibiotics within 2 weeks prior to initiation of study treatment; Active pulmonary tuberculosis infection within 1 year prior to enrollment; Active autoimmune disease requiring systemic treatment within 2 years prior to randomization; Administration of a live attenuated vaccine within 28 days prior to randomization, or anticipated need for live attenuated vaccination during study treatment; Participation in any other clinical drug trial within 4 weeks or 5 half-lives (whichever is longer) of the last study drug administration prior to randomization; Major surgery (other than diagnostic procedure or biopsy) within 28 days prior to randomization; invasive minor surgery within 7 days prior to the first dose; or presence of a non-healing wound; Currently has active autoimmune disease or a history of autoimmune disease with potential recurrence; Active hepatitis B or active hepatitis C; History of immunodeficiency or organ transplantation; Known hypersensitivity to any component of HRS-4642; or known severe hypersensitivity to any of the combination antitumor agents (including SHR-1316, gemcitabine, and nab-paclitaxel); Uncontrolled psychiatric illness, or known alcoholism, drug abuse, substance dependence, criminal detention, or other conditions that may interfere with completion of study procedures; Distant metastatic lesions confirmed by imaging; Symptomatic moderate or severe ascites; uncontrolled or moderate-to-large pleural effusion or pericardial effusion; Carotid ultrasound demonstrating ≥ 50% stenosis, or carotid plaques with ≥ 2 high-risk features; Clinically significant acute or chronic pancreatitis.