Systemic Treatment-naïve Pancreatic CancerPhase 3NCT07900789
HRS-4642 Combined With Antitumor Agents for the Treatment of Perioperative Pancreatic Cancer
A Phase 3 study testing HRS -4642 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection, HRS -4642 + Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection and Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection in people with Systemic Treatment-naïve Pancreatic Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Treatment-naïve Pancreatic Cancer
- What is being tested?
- HRS -4642 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection, HRS -4642 + Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection and Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 825 participants
- Where
- 2 sitesChina
- Study dates
- Oct 2026to 30 Dec 2030
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.-
Who cannot join
- Prior systemic therapy for pancreatic cancer, including neoadjuvant chemotherapy or radiotherapy.
- Distant metastatic lesions confirmed by imaging.
- 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.
- Currently has active autoimmune disease or a history of autoimmune disease with potential recurrence.
- 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.
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- Symptomatic moderate or severe ascites; uncontrolled or moderate-to-large pleural effusion or pericardial effusion.
- 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.
- Carotid ultrasound demonstrating ≥ 50% stenosis, or carotid plaques with ≥ 2 high-risk features.
- 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.
- Clinically significant acute or chronic pancreatitis.
- Active hepatitis B or active hepatitis C.
- Active pulmonary tuberculosis infection within 1 year prior to enrollment.
- History of immunodeficiency or organ transplantation.
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Yupei Zhao
Wenming Wu
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Baiyong Shen
About this study
Official title: 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).
- Being tested
- HRS -4642 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection, HRS -4642 + Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection, Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS -4642 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for InjectionDrug
HRS -4642 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection
HRS -4642 + Gemcitabine Hydrochloride for Injection+Paclitaxel for InjectionDrug
HRS -4642 + Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection
Gemcitabine Hydrochloride for Injection+Paclitaxel for InjectionDrug
Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental group 1: HRS -4642 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for I | Experimental | Not described Receives: Drug: HRS -4642 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection |
| Experimental group 2: HRS -4642+ Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection | Experimental | Not described Receives: Drug: HRS -4642 + Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection |
| Comparator group: Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection | Active comparator | Not described Receives: Drug: Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival (EFS) based on Independent Review Committee according to RECIST v1.1
Measured: From the beginning of randomization to the time of disease progression，about 14-20 months after first dose
Secondary outcomes (9)
The rates of pathological complete response (pCR)
Assessed by the independent pathology center and the investigator
Measured: about 4-6 months after first dose
major pathological response (mPR)
Assessed by the independent pathology center and the investigator
Measured: about 4-6 months after first dose
surgical resection rate
Assessed by the investigator
Measured: about 4-6 months after first dose
R0 resection rate
Assessed by the investigator
Measured: about 4-6 months after first dose
objective response rate (ORR)
Assessed by the Independent Review Committee r and the investigator
Measured: From the beginning of randomization to the time of disease progression，about 14-20 months after first dose
disease-free survival (DFS)
Assessed by the Independent Review Committee and the investigator
Measured: From the beginning of randomization to the time of disease progression，about 14-20 months after first dose
event-free survival (EFS)
Assessed by the investigator
Measured: From the beginning of randomization to the time of disease progression，about 14-20 months after first dose
overall survival (OS)
Assessed by the investigator
Measured: From the beginning of randomization to the time of death，about 30 months after first dose
The incidence and severity of adverse events (AEs)
Assessed by the investigator
Measured: From the beginning of randomization to the time of treatment ended ，about 30 months after first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study startOct 2026 (estimated)
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Treatment-naïve Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- HRS-4642 Combination with Other Antitumor Agents compared with Standard Therapy
- Masking
- None (open label)
- Enrolment
- 825 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07900789
- Sponsor's protocol ID
- HRS-4642-303
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07900789
- Acronym / sponsor ID
- HRS-4642-303
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 825 participants (estimated)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 28 Oct 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- HRS-4642 Combination with Other Antitumor Agents compared with Standard Therapy
| Arm | Type | Receives |
|---|---|---|
| Experimental group 1: HRS -4642 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for I | Experimental | Drug: HRS -4642 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection |
| Experimental group 2: HRS -4642+ Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection | Experimental | Drug: HRS -4642 + Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection |
| Comparator group: Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection | Active comparator | Drug: Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (23 listed)
- Prior systemic therapy for pancreatic cancer, including neoadjuvant chemotherapy or radiotherapy.
- Distant metastatic lesions confirmed by imaging.
- 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.
- Currently has active autoimmune disease or a history of autoimmune disease with potential recurrence.
- Received systemic immunosuppressive therapy within 14 days prior to randomization.
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 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for InjectionHRS -4642 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection | Drug | Experimental group 1: HRS -4642 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for I |
| HRS -4642 + Gemcitabine Hydrochloride for Injection+Paclitaxel for InjectionHRS -4642 + Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection | Drug | Experimental group 2: HRS -4642+ Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection |
| Gemcitabine Hydrochloride for Injection+Paclitaxel for InjectionGemcitabine Hydrochloride for Injection+Paclitaxel for Injection | Drug | Comparator group: Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection |
Primary outcome
Event-Free Survival (EFS) based on Independent Review Committee according to RECIST v1.1
Time frame: From the beginning of randomization to the time of disease progression，about 14-20 months after first dose
9 secondary outcomes
The rates of pathological complete response (pCR)
Time frame: about 4-6 months after first dose
major pathological response (mPR)
Time frame: about 4-6 months after first dose
surgical resection rate
Time frame: about 4-6 months after first dose
R0 resection rate
Time frame: about 4-6 months after first dose
objective response rate (ORR)
Time frame: From the beginning of randomization to the time of disease progression，about 14-20 months after first dose
disease-free survival (DFS)
Time frame: From the beginning of randomization to the time of disease progression，about 14-20 months after first dose
event-free survival (EFS)
Time frame: From the beginning of randomization to the time of disease progression，about 14-20 months after first dose
overall survival (OS)
Time frame: From the beginning of randomization to the time of death，about 30 months after first dose
The incidence and severity of adverse events (AEs)
Time frame: From the beginning of randomization to the time of treatment ended ，about 30 months after first dose
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 28 Oct 2026.
- Individual participant dataSharing planned: Undecided
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HRS -4642 + SHR-1316+ Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection, HRS -4642 + Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection and Gemcitabine Hydrochloride for Injection+Paclitaxel for Injection in people with Systemic Treatment-naïve Pancreatic Cancer, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 2 sites 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 23 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Meng Qin (+86 0518-82342973, meng.qin.mq8@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (EFS) based on Independent Review Committee according to RECIST v1.1 (time frame: From the beginning of randomization to the time of disease progression，about 14-20 months after first dose). 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 28 Oct 2026.