Pancreatic CancerPhase 2NCT07691593
Neoadjuvant HRS-4642 Plus Chemotherapy With or Without Immunotherapy for Pancreatic Cancer
A Phase 2 study testing HRS-4642+NALIRIFOX and HRS-4642+NALIRIFOX+Adebrelimab in people with Pancreatic Cancer, run by Changhai Hospital.
Trial summary
To evaluate the safety and efficacy of neoadjuvant HRS-4642 plus chemotherapy with or without adebrelimab in patients with pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- HRS-4642+NALIRIFOX and HRS-4642+NALIRIFOX+Adebrelimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Oct 2028
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female participants aged 18-70 (including those who are 18 and 70 years old)；
- Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);
- Life expectancy ≥ 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Adequate marrow and organ function;
Who cannot join
- Prior receipt of any anti-tumor therapy, including but not limited to systemic chemotherapy, radiotherapy, interventional therapy, immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine therapy;
- Presence of distant metastatic lesions confirmed by imaging;
- Known hypersensitivity to the investigational drug or any of its excipients;
- Presence of any serious or uncontrolled systemic disease;
- History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
- Clinically significant acute or chronic pancreatitis;
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- Participation in any interventional clinical trial involving drugs or medical devices within 4 weeks prior to the first administration of study treatment;
- Vaccination with live or live-attenuated vaccines within 4 weeks prior to the first dose of the investigational drug;
- Any other condition that, in the judgment of the investigator, makes the subject unsuitable for enrollment.
About this study
Official title: An Exploratory Clinical Study of HRS-4642 in Combination With Chemotherapy With or Without Adebrelimab as Neoadjuvant Therapy for Pancreatic Cancer
To evaluate the safety and efficacy of neoadjuvant HRS-4642 plus chemotherapy with or without adebrelimab in patients with pancreatic ductal adenocarcinoma.
- Conditions
- Pancreatic Cancer
- Being tested
- HRS-4642+NALIRIFOX, HRS-4642+NALIRIFOX+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+NALIRIFOXDrug
HRS-4642+NALIRIFOX
HRS-4642+NALIRIFOX+AdebrelimabDrug
HRS-4642+NALIRIFOX+Adebrelimab
HRS-4642+NALIRIFOX+AdebrelimabDrug
HRS-4642+NALIRIFOX+Adebrelimab
| Study group | Role | What they receive |
|---|---|---|
| Arm 1：HRS-4642+NALIRIFOX | Experimental | Not described Receives: Drug: HRS-4642+NALIRIFOX |
| Arm 2：HRS-4642+NALIRIFOX+Adebrelimab（4 cycles of neoadjuvant therapy） | Experimental | Not described Receives: Drug: HRS-4642+NALIRIFOX+Adebrelimab |
| Arm 3：HRS-4642+NALIRIFOX+Adebrelimab（6 cycles of neoadjuvant therapy） | Experimental | Not described Receives: Drug: HRS-4642+NALIRIFOX+Adebrelimab |
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 30 days or within 60 days after the last dose of adebrelimab for the last dose
Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
Measured: Once every 2 cycles from enrollment through the neoadjuvant and adjuvant therapy periods or until disease progression; the evaluation period is up to 6 months
Secondary outcomes (3)
Pathologic Complete Response Rate (pCR)
Measured: At the time of surgery
R0 (microscopically margin-negative) resection rate
Measured: At the time of surgery
Major Pathologic Response Rate (MPR)
Measured: At the time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study startJun 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (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 Changhai 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
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07691593
- Sponsor's protocol ID
- PANC-HRS4642-SHR1316-NALIRIFOX
- Status last verified
- Jun 2026
- First submitted
- 29 Jun 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 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 Chemotherapy With or Without Adebrelimab as Neoadjuvant Therapy for Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT07691593
- Acronym / sponsor ID
- PANC-HRS4642-SHR1316-NALIRIFOX
- Conditions
- Pancreatic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 9 Jul 2026 (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 neoadjuvant HRS-4642 plus chemotherapy with or without adebrelimab in patients with pancreatic ductal adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1：HRS-4642+NALIRIFOX | Experimental | Drug: HRS-4642+NALIRIFOX |
| Arm 2：HRS-4642+NALIRIFOX+Adebrelimab（4 cycles of neoadjuvant therapy） | Experimental | Drug: HRS-4642+NALIRIFOX+Adebrelimab |
| Arm 3：HRS-4642+NALIRIFOX+Adebrelimab（6 cycles of neoadjuvant therapy） | Experimental | Drug: HRS-4642+NALIRIFOX+Adebrelimab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female participants aged 18-70 (including those who are 18 and 70 years old)；
- Pathologically or cytologically confirmed ductal adenocarcinoma of the pancreas; and subjects must have at least one measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1);
- Life expectancy ≥ 12 weeks;
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
- Adequate marrow and organ function;
Key exclusion criteria (9 listed)
- Prior receipt of any anti-tumor therapy, including but not limited to systemic chemotherapy, radiotherapy, interventional therapy, immunotherapy, targeted therapy, and anti-tumor traditional Chinese medicine therapy;
- Presence of distant metastatic lesions confirmed by imaging;
- Known hypersensitivity to the investigational drug or any of its excipients;
- Presence of any serious or uncontrolled systemic disease;
- History of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
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-4642+NALIRIFOXHRS-4642+NALIRIFOX | Drug | Arm 1：HRS-4642+NALIRIFOX |
| HRS-4642+NALIRIFOX+AdebrelimabHRS-4642+NALIRIFOX+Adebrelimab | Drug | Arm 2：HRS-4642+NALIRIFOX+Adebrelimab（4 cycles of neoadjuvant therapy） |
| HRS-4642+NALIRIFOX+AdebrelimabHRS-4642+NALIRIFOX+Adebrelimab | Drug | Arm 3：HRS-4642+NALIRIFOX+Adebrelimab（6 cycles of neoadjuvant therapy） |
Primary outcome
Adverse events (AEs)
Time frame: From the first drug administration to within 30 days or within 60 days after the last dose of adebrelimab for the last dose
Objective Response Rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1)
Time frame: Once every 2 cycles from enrollment through the neoadjuvant and adjuvant therapy periods or until disease progression; the evaluation period is up to 6 months
3 secondary outcomes
Pathologic Complete Response Rate (pCR)
Time frame: At the time of surgery
R0 (microscopically margin-negative) resection rate
Time frame: At the time of surgery
Major Pathologic Response Rate (MPR)
Time frame: At the time of surgery
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 9 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-4642+NALIRIFOX and HRS-4642+NALIRIFOX+Adebrelimab in people with Pancreatic Cancer, run by Changhai Hospital.
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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 or within 60 days after the last dose of adebrelimab 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?
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 9 Jul 2026.