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Pancreatic NeoplasmsPhase 2NCT05481463

Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced Pancreatic Cancer

A Phase 2 study testing Surufatinib and TAS-102 in people with Pancreatic Neoplasms, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 TAS-102 in third-line and later-line therapy of patients with advanced 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 and TAS-102
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteChina
Study dates
30 Jan 2023to 10 May 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 previously received at least two systemic therapies for locally advanced or metastatic pancreatic cancer; patients with BRCA1/2 germline mutations have previously received platinum-containing regimens
  • Patients must have at least one measurable liver metastases (RECIST 1.1)
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  • 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 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
  • 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
  • Clinically significant electrolyte abnormality
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  • 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 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 Open-label, Single-arm, Single-center, Phase II Clinical Study of Surufatinib Combined With TAS-102 in Third-line and Later-line Therapy of Patients With Advanced 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 TAS-102 in third-line and later-line therapy of patients with advanced pancreatic cancer

Read the detailed description

surufatinib:250mg,QD,Q4W TAS-102:35mg/m2,D1-5,D8-12,Q4W

Being tested
Surufatinib, TAS-102
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

    surufatinib,250mg, qd, po, 28 days for a cycle

  • TAS-102Drug

    TAS-102,35mg/m2, po, d1-5, d8-12, bid, 28 days for a cycle

Study groups in NCT05481463
Study groupRoleWhat they receive
surufatinib combined with TAS-102ExperimentalSurufatinib 250mg,TAS-102 35mg/m2
Receives: Drug: Surufatinib; Drug: TAS-102

What is being measured

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

  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

Secondary outcomes (5)

  1. 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

  2. overall survival (OS)

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

    Measured: up to 24 months

  3. 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

  4. quality of life (QoL)

    Assessing the quality of life of cancer patients by QLQ-C30

    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 start30 Jan 2023
  3. Primary completion31 Mar 2025
  4. Study completion10 May 2025

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05481463
Sponsor's protocol ID
HMPL-012-SPRING-P104
Status last verified
Mar 2025
First submitted
28 Jul 2022
Last updated
28 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lu Y, Lin Q, Mo Y, Liu F, Zhang M, Huang R, Wang Y, Wang Y, Wang Z, Luo H, Guo G, Chen J, Liu Y, He M, Wang F, Wang F, Zhang D. Efficacy and safety of TAS-102 plus Surufatinib in third and later line metastatic pancreatic cancer: a prospective, single center and biomarker exploratory, phase II study. Mol Cancer. 2025 Oct 2;24(1):235. doi: 10.1186/s12943-025-02437-0.

    PubMed 41039600

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Surufatinib and TAS-102 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 9 inclusion and 19 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: finished, as of the sponsor's last update on 28 May 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-Free Survival (PFS) (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 NCT05481463, which also lists 1 linked publication.

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 May 2025.

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