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Pancreatic CancerPhase 2NCT07131514

HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

A Phase 2 study testing HRS-4642+AG +Adebrelimab in people with Pancreatic Cancer, run by Ruijin Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

To evaluate the safety and efficacy of HRS-4642 in Combination With AG and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pancreatic Cancer
What is being tested?
HRS-4642+AG +Adebrelimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
25 Aug 2025to Dec 2027
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: ≥18 and ≤80 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;
  • Imaging evaluation met the NCCN guidelines definition of resectable pancreatic cancer (including high-risk resectable) and borderline resectable pancreatic cancer.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
  • Life expectancy ≥ 12 weeks;
  • 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 6 months after the last study administration;
  • Patients volunteered to participate in this study and signed informed consent;

Who cannot join

  • Previously received any anti-tumor therapy;
  • the presence of distant metastatic lesions diagnosed by imaging;
  • 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;
  • Received live and attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
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  • previous allogeneic hematopoietic stem cell transplantation or organ transplantation;
  • 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;
  • 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);
  • with congenital or acquired immunodeficiencies such as human immunodeficiency virus (HIV) infection, active hepatitis B (positive hepatitis B virus surface antigen [HBsAg] test result at screening together with an HBVDNA test value of ≥10,000 copies/ml [2000 IU/ ml]), active hepatitis C (hepatitis C virus antigen [HCV-antibodies] at screening), or active hepatitis C (hepatitis C virus antitoxin [HCVantibodies] at screening).antibody [HCV-Ab] positive at screening and HCV-RNA positive at the same time), or co-infection with hepatitis B and hepatitis C;
  • 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 (except when the investigator determines that abnormally elevated amylase and/or lipase are associated with pancreatic cancer);
  • Patients with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to: autoimmune hepatitis, interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, and hyperthyroidism; patients with asthma that has completely resolved in childhood and does not require any intervention in adulthood can be included; patients with asthma that requires medical intervention with bronchodilators cannot be Inclusion);
  • Systemic treatment 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 and adrenal hormone replacement therapy at doses
  • ≤10 mg/day of prednisone efficacy permitted in the absence of active autoimmune disease
  • 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.

Baiyong shen, Dr contact

008613901943778

shenby@shsmu.edu.cn

China1 site, 1 recruiting

  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai

    Recruiting

Other trials in China

About this study

Official title: An Exploratory Clinical Study of HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

To evaluate the safety and efficacy of HRS-4642 in Combination With AG and Adebrelimab for Neoadjuvant and Adjuvant Treatment of Pancreatic Cancer

Read the detailed description

This study is an open, single center, exploratory clinical trial aimed at evaluating the safety and efficacy of HRS-4642 in combination with gemcitabine and albumin-bound paclitaxel and Adebrelimab for neoadjuvant and adjuvant treatment of pancreatic cancer

Being tested
HRS-4642+AG +Adebrelimab
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-4642+AG +AdebrelimabDrug

    HRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab will be administrated per dose level in which the patients are assigned.

Study groups in NCT07131514
Study groupRoleWhat they receive
HRS-4642+AG +AdebrelimabExperimentalHRS-4642 in Combination With Gemcitabine and Albumin-bound Paclitaxel and Adebrelimab will be administrated per dose level in which the patients are assigned.
Receives: Drug: HRS-4642+AG +Adebrelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events (AEs)

    AEs are assessed by NCI-CTCAE v5.0

    Measured: From the first drug administration to within 30 days for the last dose

  2. Objective Response Rate (ORR)

    Evaluated by RECIST v1.1

    Measured: Up to approximately 6 months

Secondary outcomes (5)

  1. pathologic complete response (pCR)

    Number of subjects achieving pCR as a percentage of subjects

    Measured: At the time of surgery

  2. Overall survival (OS)

    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 12 months

  3. major pathologic response (MPR, CAP Score 0-1)

    Number of Subjects Achieving MPR as a Percentage of Subjects

    Measured: At the time of surgery

  4. Disease-free survival (DFS)

    For subjects who achieved R0/R1 resection, the time from the start of surgery to disease recurrence (local or distant) or death from any cause, whichever occurs first

    Measured: Up to approximately 6 months

  5. Event-free survival (EFS)

    The time from the first dose of neoadjuvant therapy to the occurrence of any event; events include the occurrence of imaging disease progression (based on the date of the imaging test), the occurrence of disease recurrence (local recurrence or distant recurrence) after surgery, and death from any cause, based on the time of the first occurrence

    Measured: Up to approximately 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2025
  2. Study start25 Aug 2025
  3. Primary completionJun 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07131514
Sponsor's protocol ID
PANC-PERI-IIT-HRS4642-AG-PD-L1
Status last verified
Dec 2025
First submitted
13 Aug 2025
Last updated
27 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HRS-4642+AG +Adebrelimab in people with Pancreatic Cancer, run by Ruijin 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 27 May 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 Baiyong shen, Dr (008613901943778, shenby@shsmu.edu.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 30 days for the last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07131514.

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 27 May 2026.

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