Pancreatic CancerPhase 2NCT06938282
An Exploratory Clinical Study of HRS-4642 in Combination With Immunotherapy and Chemotherapy for Pancreatic Cancer
A Phase 2 study testing HRS-4642 in people with Pancreatic Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
To evaluate the safety and efficacy of HRS-4642 in combination with immunotherapy and chemotherapy in borderline resectable, locally advanced/metastatic pancreatic cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- HRS-4642
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2025to 30 Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: ≥18 years old, male or female;
- Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
- Arm 1 included patients with locally advanced or metastatic pancreatic cancer whose imaging assessment met the guideline definition, and Arm 2 included patients with borderline resectable pancreatic cancer whose imaging assessment met the guideline definition;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Expected survival ≥ 6 months;
- Adequate marrow and organ function;
- Female participants of childbearing age must undergo a pregnancy test within one week before the start of the study medication, and the result is negative. They are willing to use a medically recognized and efficient contraceptive method during the study period and within three months after the last administration of the study medication; For male participants whose partners are women of childbearing age, they should agree to use effective methods of contraception during the study period and within 3 months after the last study administration;
- Patients volunteered to participate in this study and signed informed consent.
Who cannot join
- Previously received any systemic therapy, including systemic chemotherapy, immunotherapy, targeted therapy, and anti-tumor Chinese medicine;
- Known hypersensitivity to the study drug or any of its components;
- Previous or concurrent other malignant tumors;
- Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;
- Live and attenuated vaccines were administered within 4 weeks prior to the first dose of study drug;
- Previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
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- Active CNS metastases (including CNS metastases with clinical symptoms, brain edema, CNS metastases that have been treated with or required steroid medications in the last 28 days, and CNS metastases that are new or have shown disease progression);
- Symptomatic, advanced patients with visceral dissemination and short-term risk of life-threatening complications (including patients with uncontrolled large amounts of exudate [thoracic, pericardial, peritoneal]); if effusion is drained, those who have been stable for at least 2 weeks after drainage are eligible for enrollment (topical plasmapheresis is permitted on a routine basis prior to signing an informed consent form);
- Patients with severe cardiovascular arterial thromboembolism (e.g., myocardial infarction, unstable angina, stroke), NYHA class 2 or greater cardiac insufficiency, and clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
- Individuals with interstitial lung disease, non-infectious pneumonia or severe and uncontrolled medical illness, acute infections, recent history of major surgery (within 28 days or not yet recovered from side effects);
- Individuals with congenital or acquired immunodeficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (positive hepatitis B virus surface antigen [HBsAg] test result at screening along with a HBV-DNA test value of ≥10,000 copies/ml [2000 IU/ml]), active hepatitis C (positive hepatitis C virus antibody [HCV-Ab] test result at screening), or a combination of hepatitis B and hepatitis B and HCV-RNA. Positive HCV-Ab [HCV-Ab] test result at screening stage (also HCV-RNA positive) or co-infection with Hepatitis B and Hepatitis C;
- Patients with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enterocolitis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, and hyperthyroidism; patients with asthma that has resolved completely in childhood and does not require any intervention in adulthood may be included; patients with asthma that requires medical intervention with bronchodilators may not be included);
- Systemic therapy with corticosteroids (>10 mg/day of prednisone or other equivalent hormone) or other immunosuppressive agents within 2 weeks prior to the first dose; inhaled or topical corticosteroids are allowed in the absence of active autoimmune disease, as well as adrenal hormone replacement therapy at doses of ≤ 10 mg/day of prednisone at efficacious doses;
- Presence of clinically significant acute or chronic pancreatitis; patients at high risk for pancreatitis, e.g., serum amylase and/or lipase concentrations ≥3 times ULN;
- Other situations that the researcher felt should not be included.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Wenquan Wang, Ph.D, 13701874954, wang.wenquan@zs-hospital.sh.cn
About this study
To evaluate the safety and efficacy of HRS-4642 in combination with immunotherapy and chemotherapy in borderline resectable, locally advanced/metastatic pancreatic cancer
- Conditions
- Pancreatic Cancer
- Being tested
- HRS-4642
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-4642Drug
HRS-4642 in Combination with Immunotherapy and Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm1:locally advanced/metastatic pancreatic cancer | Experimental | HRS-4642 in Combination with Immunotherapy and Chemotherapy Receives: Drug: HRS-4642 |
| Arm 2: borderline resectable pancreatic cancer | Experimental | HRS-4642 in Combination with Immunotherapy and Chemotherapy Receives: Drug: HRS-4642 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs)
Measured: From the first drug administration to within 90 days for the last dose
Arm 1:Objective Response Rate (ORR)
Measured: Up to approximately 12 months
Arm 2:18m-OS rate
Overall survival (OS)：The OS is defined as time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Measured: Up to approximately 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start23 Jun 2025
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06938282
- Sponsor's protocol ID
- ZSPAC-13
- Status last verified
- Aug 2026
- First submitted
- 14 Apr 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of HRS-4642 in Combination With Immunotherapy and Chemotherapy for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT06938282
- Acronym / sponsor ID
- ZSPAC-13
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 22 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and efficacy of HRS-4642 in combination with immunotherapy and chemotherapy in borderline resectable, locally advanced/metastatic pancreatic cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm1:locally advanced/metastatic pancreatic cancer | Experimental | Drug: HRS-4642HRS-4642 in Combination with Immunotherapy and Chemotherapy |
| Arm 2: borderline resectable pancreatic cancer | Experimental | Drug: HRS-4642HRS-4642 in Combination with Immunotherapy and Chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: ≥18 years old, male or female;
- Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by RECIST v1.1;
- Arm 1 included patients with locally advanced or metastatic pancreatic cancer whose imaging assessment met the guideline definition, and Arm 2 included patients with borderline resectable pancreatic cancer whose imaging assessment met the guideline definition;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Expected survival ≥ 6 months;
Key exclusion criteria (15 listed)
- Previously received any systemic therapy, including systemic chemotherapy, immunotherapy, targeted therapy, and anti-tumor Chinese medicine;
- Known hypersensitivity to the study drug or any of its components;
- Previous or concurrent other malignant tumors;
- Participation in a clinical trial of any drug or medical device within 4 weeks prior to the first dose;
- Live and attenuated vaccines were administered within 4 weeks prior to the first dose of study drug;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-4642HRS-4642 in Combination with Immunotherapy and Chemotherapy | Drug | Arm 2: borderline resectable pancreatic cancer, Arm1:locally advanced/metastatic pancreatic cancer |
Primary outcome
Adverse events (AEs)
Time frame: From the first drug administration to within 90 days for the last dose
Arm 1:Objective Response Rate (ORR)
Time frame: Up to approximately 12 months
Arm 2:18m-OS rate
Time frame: Up to approximately 18 months
Overall survival (OS)：The OS is defined as time from the date of enrollment to data of death from any cause, or date of lost follow-up, whichever comes first, and otherwise censored at time last known alive.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-4642 in people with Pancreatic Cancer, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenquan Wang, Ph.D. (13701874954, wang.wenquan@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) (time frame: From the first drug administration to within 90 days for the last dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.