Pancreatic Cancer MetastaticPhase 2NCT05969171
A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With AG or AG in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer
A Phase 2 study testing Surufatinib, gemcitabine, nab-paclitaxel and Nab-paclitaxel, gemcitabine in people with Pancreatic Cancer Metastatic, run by Fudan University at 1 site in China.
Trial summary
This is a single-center, prospective, two cohort study to evaluate the efficacy and safety of surufatinib in combination with AG or AG alone in the first-line treatment 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 Cancer Metastatic
- What is being tested?
- Surufatinib, gemcitabine, nab-paclitaxel and Nab-paclitaxel, gemcitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 5 Dec 2023to 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
- Subjects must meet all of the following criteria for enrollment:
- The subjects voluntarily joined the study and signed the informed consent with good compliance and follow-up;
- Unresectable, locally advanced or metastatic pancreatic cancer confirmed by histopathology or cytology;
- Aged between 18 and 75 (including 18 and 75), male or female;
- ECOG score: 0-1; Expected survival ≥12 weeks;
- Patients who had previously received 2 cycles of AG regimen first-line systemic therapy for locally advanced or metastatic pancreatic cancer and whose efficacy was evaluated as CR, PR, SD (excluding SD patients whose efficacy was evaluated as increased after 2 cycles of therapy);
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- Patients with postoperative distant metastasis had received adjuvant chemotherapy of one type and the distance from adjuvant therapy time \> Patients with recurrence at 6 months could be included in the group;
- At least one measurable lesion (according to RECIST 1.1 criteria); Magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement accurately measured the diameter of ≥10mm, conventional CT scan to determine the diameter of at least 20mm.
- No serious organic diseases of heart, lung, brain and other organs;
- The functions of major organs and bone marrow are basically normal:
- Blood routine: white blood cells ≥ 4.0 x 109/L, neutrophils ≥ 1.5 x 109/L, platelets ≥ 80 x 109/L, hemoglobin ≥ 90g/L;
- International Standardized ratio (INR) and activated partial thrombin time (APTT) ≤1.5× upper limit of normal value (ULN);
- Liver function: serum total bilirubin ≤ 1.5 x ULN, ALT/AST ≤ 3 x ULN, serum total biliary red ≤ 1.5 x ULN after internal/external drainage for obstructive jaundice;
- Renal function: serum creatinine ≤ 1.5 x ULN, creatinine clearance (CCr) ≥ 50mL/min;
- Normal cardiac function, left ventricular ejection fraction (LVEF)≥50% by two-dimensional echocardiography;
- Fertile male or female patients volunteered to use effective contraceptive methods, such as double screen contraceptives, condoms, oral or injectable contraceptives, intrauterine devices, etc., during the study period and within 6 months of the last study medication. All female patients will be considered fertile unless they have undergone natural menopause, artificial menopause or sterilization.
- Those who met each of the above criteria were included in the study.
Who cannot join
- The study proposal shall be excluded if any of the following criteria are met:
- Participated in clinical trials of other antitumor drugs within 4 weeks before enrollment;
- Prior treatment with VEGFR inhibitors or prior treatment with immune checkpoint inhibitors;
- Patients with BRCA1/2 germ line mutation;
- Patients with obstructive jaundice but failing to reach the expected yellow reduction;
- Have had other malignancies within the past 5 years, other than basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
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- Patients who have had or currently have any brain metastases;
- The investigators determined that liver metastases accounted for 70% or more of the total liver volume;
- Had received any surgery (except biopsy) or invasive treatment or operation within 4 weeks prior to inclusion, and the surgical incision was not completely healed (except intravenous catheterization, puncture drainage, internal/external drainage for obstructive jaundice, etc.);
- Uncontrolled pleural effusion, pericardial effusion or ascites requiring drainage;
- Local antitumor therapy, such as hepatic artery interventional embolization, liver metastasis cryoablation or radiofrequency ablation, was received within 4 weeks before enrollment;
- Electrolyte abnormalities identified by the investigator as clinically significant;
- The patient has medically uncontrolled hypertension, as follows: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
- Urine routine indicated urinary protein ≥2+ and 24-hour urinary protein volume \> 1.0g;
- Patients whose tumors are judged to be at high risk of invading vital blood vessels and causing fatal haemorrhage during the follow-up study;
- Patients with significant evidence or history of bleeding tendency within 3 months prior to enrollment (bleeding within 3 months \> 30 mL, hematemesis, black feces, blood in stool), hemoptysis (within 4 weeks \> 5 mL fresh blood); A history of hereditary or acquired bleeding or a coagulation disorder. Have clinically significant bleeding symptoms or definite bleeding tendency within 3 months, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.;
- Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \> Level 2; Ventricular arrhythmias requiring medical treatment; Electrocardiogram (ECG) showed a QT c interval ≥480 ms;
- Active or uncontrolled severe infection (≥CTCAE grade 2 infection);
- Unmitigated toxic reactions higher than CTCAE grade 2 or above due to any previous anticancer therapy, excluding grade 2 or less neurotoxicity due to alopecia, lymphocytopenia, and oxaliplatin;
- Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
- Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, which, in the investigator's judgment, the patient has a medical condition or condition that is reasonably suspected to be unsuitable for the use of the study drug (such as the presence of epileptic seizures requiring treatment), or which would interfere with the interpretation of the study results, or place the patient at high risk;
- Known human immunodeficiency virus (HIV) infection; A known history of clinically significant liver disease, including viral hepatitis [active HBV infection must be ruled out as a known carrier of hepatitis B virus (HBV), i.e. positive HBV DNA (>1×104 copies/mL or >2000 IU/ml); known hepatitis C virus infection (HCV) and HCV RNA positive (>1×103 copies /mL), or other hepatitis, cirrhosis;
- The presence of any active, known 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, pituitaritis, hyperthyroidism, etc.);
- Allergy or suspected allergy to the study drug or similar drug;
- In the investigator's judgment, the patient had other factors that might affect the study results or lead to the termination of the study, such as alcoholism, drug abuse, other serious medical conditions (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, and family or social factors that would affect the patient's safety.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University ShangHai Cancer Center
Shanghai
Jin Xu, 18017317267, xujin@fudanpci.org
About this study
Official title: A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With Gemcitabine and Nab-paclitaxel or Gemcitabine Combined With Nab-paclitaxel in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer
This is a single-center, prospective, two cohort study to evaluate the efficacy and safety of surufatinib in combination with AG or AG alone in the first-line treatment of patients with locally advanced or metastatic pancreatic cancer.
Participants with previously received AG chemotherapy for 2 cycles with no disease progression will be enrolled:
Read more
Arm 1: Surufatinib plus AG chemotherapy (q3w) until disease progression/death/withdrawn; Arm 2: AG chemotherapy (q3w) until disease progression/death/withdrawn;
During the treatment period, imaging methods were used to evaluate the tumor status every 6 weeks (±7 days) until disease progression (RECIST 1.1) or death (during the patient's treatment) or toxicity was intolerable or other criteria for termination of study treatment specified in the protocol were met, and the tumor treatment and survival status after disease progression were recorded. Safety observation indicators include: AEs, changes in laboratory values, vital signs, and changes in electrocardiogram.
- Conditions
- Pancreatic Cancer Metastatic
- Being tested
- Surufatinib, gemcitabine, nab-paclitaxel, Nab-paclitaxel, gemcitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surufatinib, gemcitabine, nab-paclitaxelDrug
Nab-paclitaxel: 125mg/m2 intravenously, d1, 8; every 3 weeks for a treatment cycle, did not exceed a maximum of 6 treatment cycles. Gemcitabine: 1000mg/m2, intravenous infusion greater than 30min, d1, 8, every 3 weeks for a treatment cycle. Surufatinib: 250mg, qd, po, every 3 weeks for a treatment cycle. Surufatinib and gemcitabine was continued until disease progression (PD, RECIST 1.1) or death (while the patient was on treatment) or toxicity became intolerant or other criteria for discontinuation of study therapy were met in the protocol. Allow adjustment of dosage according to protocol requirements, including suspension, lowering of dosage or permanent discontinuation.
Nab-paclitaxel, gemcitabineDrug
Nab-paclitaxel: 125mg/m2 intravenously, d1, 8; every 3 weeks as a treatment cycle, should not exceed a maximum of 6 treatment cycles. Gemcitabine: 1000mg/m2, intravenous infusion greater than 30min, d1, 8, every 3 weeks as a treatment cycle, treatment until toxicity intolerance or disease progression, death, or other criteria for termination of study therapy as specified in the protocol. Allow adjustment of dosage according to protocol requirements, including suspension, lowering of dosage or permanent discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Surufatinib in combination with gemcitabine and nab-paclitaxel | Experimental | Nab-paclitaxel: 125mg/m2 intravenously, d1, 8; every 3 weeks for a treatment cycle, did not exceed a maximum of 6 treatment cycles.
Gemcitabine: 1000mg/m2, intravenous infusion greater than 30min, d1, 8, every 3 weeks for a treatment cycle.
Surufatinib: 250mg, qd, po, every 3 weeks for a treatment cycle. Surufatinib and gemcitabine was continued until disease progression (PD, RECIST 1.1) or death (while the patient was on treatment) or toxicity became intolerant or other criteria for discontinuation of study therapy were met in the protocol. Allow adjustment of dosage according to protocol requirements, including suspension, lowering of dosage or permanent discontinuation. Receives: Drug: Surufatinib, gemcitabine, nab-paclitaxel |
| Nab-paclitaxel combined with gemcitabine | Active comparator | Nab-paclitaxel: 125mg/m2 intravenously, d1, 8; every 3 weeks as a treatment cycle, should not exceed a maximum of 6 treatment cycles.
Gemcitabine: 1000mg/m2, intravenous infusion greater than 30min, d1, 8, every 3 weeks as a treatment cycle, treatment until toxicity intolerance or disease progression, death, or other criteria for termination of study therapy as specified in the protocol.
Allow adjustment of dosage according to protocol requirements, including suspension, lowering of dosage or permanent discontinuation. Receives: Drug: Nab-paclitaxel, gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Measured: Defined as the time from the date of enrollment to the first documentation of disease progression or death from any cause, whichever occurs first.
Secondary outcomes (3)
Objective Response Rate
Measured: The proportion of patients whose tumors have decreased by a certain degree and remained so for a specified duration, including cases of complete response (CR) and partial response (PR). Tumor objective response is assessed using RECIST v1.1
Overall survival
Measured: Overall survival (OS) refers to the duration from the date of enrollment to the date of death due to any cause.
Disease control rate
Measured: Defined as the proportion of evaluable patients with complete response (CR), partial response (PR), or stable disease (SD) as confirmed cases. At baseline, subjects must have measurable tumor lesions; responses are evaluated according to RECIST v1.1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start5 Dec 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic Cancer MetastaticStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Xu, Fudan University
- Investigators
- Jin Xu, Principal investigator, 180 1731 7267
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05969171
- Sponsor's protocol ID
- HMPL-012-SH-PC101
- Status last verified
- Jul 2025
- First submitted
- 8 Jun 2023
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With Gemcitabine and Nab-paclitaxel or Gemcitabine Combined With Nab-paclitaxel in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT05969171
- Acronym / sponsor ID
- HMPL-012-SH-PC101
- Conditions
- Pancreatic Cancer Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Aug 2023 (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.
This is a single-center, prospective, two cohort study to evaluate the efficacy and safety of surufatinib in combination with AG or AG alone in the first-line treatment of patients with locally advanced or metastatic pancreatic cancer.
Participants with previously received AG chemotherapy for 2 cycles with no disease progression will be enrolled:
Arm 1: Surufatinib plus AG chemotherapy (q3w) until disease progression/death/withdrawn; Arm 2: AG chemotherapy (q3w) until disease progression/death/withdrawn;
During the treatment period, imaging methods were used to evaluate the tumor status every 6 weeks (±7 days) until disease progression (RECIST 1.1) or death (during the patient's treatment) or toxicity was intolerable or other criteria for termination of study treatment specified in the protocol were met, and the tumor treatment and survival status after disease progression were recorded. Safety observation indicators include: AEs, changes in laboratory values, vital signs, and changes in electrocardiogram.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surufatinib in combination with gemcitabine and nab-paclitaxel | Experimental | Drug: Surufatinib, gemcitabine, nab-paclitaxelNab-paclitaxel: 125mg/m2 intravenously, d1, 8; every 3 weeks for a treatment cycle, did not exceed a maximum of 6 treatment cycles. Gemcitabine: 1000mg/m2, intravenous infusion greater than 30min, d1, 8, every 3 weeks for a treatment cycle. Surufatinib: 250mg, qd, po, every 3 weeks for a treatment cycle. Surufatinib and gemcitabine was continued until disease progression (PD, RECIST 1.1) or death (while the patient was on treatment) or toxicity became intolerant or other criteria for discontinuation of study therapy were met in the protocol. Allow adjustment of dosage according to protocol requirements, including suspension, lowering of dosage or permanent discontinuation. |
| Nab-paclitaxel combined with gemcitabine | Active comparator | Drug: Nab-paclitaxel, gemcitabineNab-paclitaxel: 125mg/m2 intravenously, d1, 8; every 3 weeks as a treatment cycle, should not exceed a maximum of 6 treatment cycles. Gemcitabine: 1000mg/m2, intravenous infusion greater than 30min, d1, 8, every 3 weeks as a treatment cycle, treatment until toxicity intolerance or disease progression, death, or other criteria for termination of study therapy as specified in the protocol. Allow adjustment of dosage according to protocol requirements, including suspension, lowering of dosage or permanent discontinuation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- The subjects voluntarily joined the study and signed the informed consent with good compliance and follow-up;
- Unresectable, locally advanced or metastatic pancreatic cancer confirmed by histopathology or cytology;
- Aged between 18 and 75 (including 18 and 75), male or female;
- ECOG score: 0-1; Expected survival ≥12 weeks;
- Patients who had previously received 2 cycles of AG regimen first-line systemic therapy for locally advanced or metastatic pancreatic cancer and whose efficacy was evaluated as CR, PR, SD (excluding SD patients whose efficacy was evaluated as increased after 2 cycles of therapy);
Key exclusion criteria (25 listed)
- Participated in clinical trials of other antitumor drugs within 4 weeks before enrollment;
- Prior treatment with VEGFR inhibitors or prior treatment with immune checkpoint inhibitors;
- Patients with BRCA1/2 germ line mutation;
- Patients with obstructive jaundice but failing to reach the expected yellow reduction;
- Have had other malignancies within the past 5 years, other than basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
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 |
|---|---|---|
| Surufatinib, gemcitabine, nab-paclitaxelNab-paclitaxel: 125mg/m2 intravenously, d1, 8; every 3 weeks for a treatment cycle, did not exceed a maximum of 6 treatment cycles. Gemcitabine: 1000mg/m2, intravenous infusion greater than 30min, d1, 8, every 3 weeks for a treatment cycle. Surufatinib: 250mg, qd, po, every 3 weeks for a treatment cycle. Surufatinib and gemcitabine was continued until disease progression (PD, RECIST 1.1) or death (while the patient was on treatment) or toxicity became intolerant or other criteria for discontinuation of study therapy were met in the protocol. Allow adjustment of dosage according to protocol requirements, including suspension, lowering of dosage or permanent discontinuation. | Drug | Surufatinib in combination with gemcitabine and nab-paclitaxel |
| Nab-paclitaxel, gemcitabineNab-paclitaxel: 125mg/m2 intravenously, d1, 8; every 3 weeks as a treatment cycle, should not exceed a maximum of 6 treatment cycles. Gemcitabine: 1000mg/m2, intravenous infusion greater than 30min, d1, 8, every 3 weeks as a treatment cycle, treatment until toxicity intolerance or disease progression, death, or other criteria for termination of study therapy as specified in the protocol. Allow adjustment of dosage according to protocol requirements, including suspension, lowering of dosage or permanent discontinuation. | Drug | Nab-paclitaxel combined with gemcitabine |
Primary outcome
Progression-free survival
Time frame: Defined as the time from the date of enrollment to the first documentation of disease progression or death from any cause, whichever occurs first.
3 secondary outcomes
Objective Response Rate
Time frame: The proportion of patients whose tumors have decreased by a certain degree and remained so for a specified duration, including cases of complete response (CR) and partial response (PR). Tumor objective response is assessed using RECIST v1.1
Overall survival
Time frame: Overall survival (OS) refers to the duration from the date of enrollment to the date of death due to any cause.
Disease control rate
Time frame: Defined as the proportion of evaluable patients with complete response (CR), partial response (PR), or stable disease (SD) as confirmed cases. At baseline, subjects must have measurable tumor lesions; responses are evaluated according to RECIST v1.1
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 30 Jul 2025.
- Individual participant dataSharing planned: No
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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.
Jin Xu principal investigator
180 1731 7267
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surufatinib, gemcitabine, nab-paclitaxel and Nab-paclitaxel, gemcitabine in people with Pancreatic Cancer Metastatic, run by Fudan 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 17 inclusion and 25 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 30 Jul 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?
Contact Jin Xu (180 1731 7267, xujin@fudanpci.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: Defined as the time from the date of enrollment to the first documentation of disease progression or death from any cause, whichever occurs first.). 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 30 Jul 2025.