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Pancreatic NeoplasmsPhase 2NCT05481476

Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer

A Phase 2 study testing Surufatinib, Sintilimab and AG in people with Pancreatic Neoplasms, run by Sun Yat-sen University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is a single-center, single-arm, open-label, phase 2 clinical study, to explore the efficacy and safety of surufatinib combined with sintilimab and AG in first-line therapy of patients with locally advanced or metastatic pancreatic cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Pancreatic Neoplasms
What is being tested?
Surufatinib, Sintilimab and AG
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
12 Dec 2022to 31 Dec 2026
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent has been signed
  • Histologically or cytologically confirmed unresectable, locally advanced or metastatic pancreatic cancer
  • Age ≥ 18 years, ≤75 years, male or female
  • ECOG PS：0-1, expected overall survival ≥12 months
  • Patients who have not previously received systemic therapy for locally advanced or metastatic pancreatic cancer
  • Patients with distant metastases after surgery, who have received one regimen of adjuvant chemotherapy and have recurred > 6 months from adjuvant therapy can be enrolled
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  • Patients must have at least one measurable liver metastases (RECIST 1.1)
  • No serious organic diseases of the heart, lungs, brain and other organs
  • Patients must have adequate organ and bone marrow function
  • Women of childbearing age must have a negative pregnancy test within the first day of the study, and contraceptive methods should be taken during the study until 6 months after the last administration

Who cannot join

  • Participated in clinical trials of other anti-tumor drugs within 4 weeks before enrollment
  • Previously received VEGFR inhibitors or immune checkpoint inhibitors
  • Patients with BRCA1/2 germline mutations
  • Patients with obstructive jaundice but less than expected jaundice
  • Patients had other malignant tumors in the past 5 years, except for the cured skin basal cell carcinoma and cervical carcinoma in situ
  • Patients previously had brain metastasis or current brain metastasis
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  • Investigator determines that the liver metastases account for 70% or more of the total liver volume
  • Received any operation (except biopsy) or invasive treatment or operation (except venous catheterization, puncture and drainage, internal/external drainage surgery for obstructive jaundice, etc.) within 4 weeks before enrollment
  • Received local anti-tumor therapy such as hepatic artery interventional embolization, cryoablation or radiofrequency ablation of liver metastases within 4 weeks before enrollment
  • Clinically significant electrolyte abnormality
  • Patient currently has uncontrolled hypertension, defined as: systolic blood pressure > 140mmHg or diastolic blood pressure > 90mmHg
  • Proteinuria ≥ 2+ (1.0g/24hr)
  • Patients whose tumor is highly likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study period as judged by the investigator
  • Have evidence or history of bleeding tendency within 3 months, Significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment
  • Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; NYHA classification > 2 Grade; ventricular arrhythmia requiring medical therapy; ECG showing QTc interval ≥ 480 ms
  • Active or uncontrolled serious infection (≥CTCAE grade 2 infection)
  • Unrelieved toxic reactions ≥ CTCAE grade 2 due to any previous anticancer treatment, excluding alopecia, lymphopenia and neurotoxicity of ≤ grade 2 caused by oxaliplatin
  • Pregnant or lactating women
  • Any other disease, with clinically significant metabolic abnormalities, physical examination abnormalities or laboratory abnormalities, according to the judgment of investigator that the patient is not suitable for the the study drug (such as having epileptic seizures and require treatment), or would affect the interpretation of study results, or put patients at high risk
  • Clinical confirmed human immunodeficiency virus (HIV) infection, history of clinically significant liver disease, including viral hepatitis (hepatitis B / C (HBV DNA Positive[1×104 copies/mL or >2000 IU/ml], HCV RNA positive[>1×103 copies/mL]), or other hepatitis, cirrhosis])
  • Patients with autoimmune disease or suspected autoimmune disease (including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, enteritis, multiple Sclerosis, vasculitis, glomerulonephritis, uveitis, hypophysitis, hyperthyroidism, etc.)
  • Patients who are allergic or suspected to be allergic to the study drug or similar drugs
  • Patients have other factors that may affect the results of the study or cause the study to be terminated halfway, such as alcoholism, drug abuse, other serious diseases (including mental diseases) that require concomitant treatment, and serious laboratory abnormalities. Accompanied by family or social factors, which will affect the safety of patients

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer center of SunYat-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Single-center, Single-arm, Phase II Clinical Study of Surufatinib Combined With Sintilimab and AG in First-line Therapy of Patients With Locally Advanced or Metastatic Pancreatic Cancer

This is a single-center, single-arm, open-label, phase 2 clinical study, to explore the efficacy and safety of surufatinib combined with sintilimab and AG in first-line therapy of patients with locally advanced or metastatic pancreatic cancer.

Being tested
Surufatinib, Sintilimab, AG
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurufatinibDrug

    250mg, qd, po, 21 days for a cycle

  • SintilimabDrug

    200mg, ivgtt, d1, 21 days for a cycle, up to 2 years

  • AGDrug

    nab-paclitaxel (125mg/ m2, ivgtt, d1, 8), Gemcitabine (1000mg/ m2, intravenous infusion over 30min, d1, 8), 21 days for a cycle, up to 6 cycles

Study groups in NCT05481476
Study groupRoleWhat they receive
surufatinib combined with sintilimab and AGExperimentalNot described
Receives: Drug: Surufatinib; Drug: Sintilimab; Drug: AG

What is being measured

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

  1. objective response rate (ORR)

    Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.

    Measured: up to 24 months

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator

    Measured: up to 24 months

  2. disease control rate (DCR)

    DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator

    Measured: up to 24 months

  3. overall survival (OS)

    OS is the time from enrollment to death due to any cause.

    Measured: up to 24 months

  4. Molecular markers and imaging parameters predicting therapeutic efficacy

    Peripheral blood was collected from patients during the screening period, treatment period and safety follow-up period, and serum pathological examinations were performed; tumor imaging evaluation added elastography

    Measured: up to 24 months

  5. adverse events (AE)

    overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.

    Measured: up to 24 months

Timeline

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

  1. First posted1 Aug 2022
  2. Study start12 Dec 2022
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2026 (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
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05481476
Sponsor's protocol ID
HMPL-012-SPRING-P103
Status last verified
Aug 2025
First submitted
28 Jul 2022
Last updated
4 Sep 2025
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 Surufatinib, Sintilimab and AG in people with Pancreatic Neoplasms, run by Sun Yat-sen University 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 10 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. 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?

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?

objective response rate (ORR) (time frame: up to 24 months). 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 NCT05481476.

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 4 Sep 2025.

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