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Pancreatic CancerPhase 1/2NCT05218889

Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer

A Phase 1/2 study testing surufatinib + camrelizumab + nab-paclitaxel + S-1 and nab-paclitaxel + gemcitabine in people with Pancreatic Cancer and PDAC - Pancreatic Ductal Adenocarcinoma, run by Chinese PLA General Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study is designed to explore the efficacy and safety of surufatinib combined with camrelizumab and AS (nab-paclitaxel and S-1) as first-line treatment compared with AG (nab-paclitaxel and gemcitabine) in unresectable advanced or metastatic pancreatic cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
surufatinib + camrelizumab + nab-paclitaxel + S-1 and nab-paclitaxel + gemcitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
4 Aug 2021to Jun 2025
Phase
Phase 1/2
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

  • Have fully understood this study and voluntarily signed the informed consent form;
  • Patients with histologically or cytologically confirmed unresectable, locally advanced, or metastatic pancreatic ductal adenocarcinoma;
  • Age 18-75 years old (inclusive);
  • No prior systemic therapy for advanced pancreatic carcinoma;
  • ECOG PS 0-1;
  • Must have at least one measurable lesion, with the longest diameter of at least 10 mm as measured by spiral CT scan, or at least 20 mm as measured by conventional CT scan (according to Response Evaluation Criteria in Solid Tumors, i.e. RECIST v1.1);
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  • Expected survival ≥ 3 months;
  • The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors within *14 days before enrollment is not allowed):
  • Absolute neutrophil count ≥1.5×109/L; Platelets ≥100×109/L; Haemoglobin ≥90 g/L; Total bilirubin < 1.5 × ULN; ALT and/or AST < 1.5 × ULN ( < 3 × ULN for patients with metastases to liver); Serum creatinine < 1.5 × ULN; Endogenous creatinine clearance ≥50 mL/min;
  • Women of childbearing potential must use effective contraceptive measures;
  • Good compliance and cooperative with follow-up.

Who cannot join

  • Unable to comply with the study protocol or study procedures;
  • Previously received treatment with VEGFR inhibitors, or previously used ICI treatment;
  • Participating in or having participated in other drug clinical trials within 4 weeks prior to enrollment;
  • Have received transfusion therapy, blood products, and hematopoietic factors, such as albumin and G-CSF, within 14 days prior to enrollment;
  • Brachytherapy (radioactive seed implantation) within 60 days prior to enrollment;
  • Have received other systemic anti-tumor treatments within 4 weeks prior to enrollment, including chemotherapy, signal transduction inhibitors, hormone therapy, and immunotherapy;
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  • Have received any surgery or invasive treatment or procedure within 4 weeks prior to enrollment (excluding intravenous catheterization, paracentesis drainage, etc.);
  • Undergone major surgery within 60 days prior to enrollment or the surgical incision has not completely healed;
  • Have received local anti-tumor treatments within 4 weeks prior to enrollment, such as hepatic arterial interventional embolism, cryoablation or radiofrequency ablation of metastases to liver;
  • The patient currently has hypertension uncontrolled by medication, defined as: blood pressure systolic ≥140 mmHg and/or blood pressure diastolic ≥90 mmHg;
  • Protein urine ≥2+, or 24-hour protein urine amount ≥1.0 g on urinalysis;
  • Uncontrollable malignant ascites (defined as ascites that cannot be controlled by diuretics or paracentesis as judged by the investigator);
  • Clinically significant electrolyte abnormalities as judged by the investigator;
  • Liver metastases accounted for half or more of the total liver volume as determined by the investigator;
  • Clinically significant cardiovascular disorders, including but not limited to acute myocardial infarction within 6 months prior to enrollment, severe/unstable angina pectoris, or coronary artery bypass surgery; cardiac failure congestive with NYHA classification > Class II; ventricular arrhythmia requiring drug therapy; LVEF (left ventricular ejection fraction) <50%;
  • Hemorrhage events of ≥ Grade 3 occurring within 4 weeks prior to enrollment;
  • Patients who, within 3 months prior to enrollment, have clear evidence or history of haemorrhagic tendency (hemorrhage >30 mL within 3 months, occurrence of haematemesis, melena, haematochezia), haemoptysis (fresh blood >5 mL within 4 weeks), or have experienced thromboembolic events within 12 months (including stroke events and/or transient ischaemic attack);
  • INR > 1.5 or APTT > 1.5×ULN, or the patient is currently taking anticoagulants;
  • Currently, the patient has poorly controlled diabetes mellitus (after standard treatment, fasting glucose concentration ≥ CTCAE Grade 2);
  • The patient currently has any disease or condition that affects drug absorption, or the patient is unable to take surufatinib orally;
  • Active or uncontrolled severe infection (≥ CTCAE Grade 2 infection);
  • Known HIV infection;
  • Known history of clinically significant liver disease, including hepatitis viral [subjects known to be carriers of HBV must be excluded if they have active HBV infection, i.e., HBV DNA positive (>1×104 copies/mL or >2000 IU/mL); known HCV infection with HCV RNA positive (>1×103 copies/mL)], or other hepatitis, hepatic cirrhosis;
  • The patient currently has CNS metastasis or a history of brain metastasis;
  • Patients who currently have gastrointestinal diseases such as active gastric and duodenal ulcer, colitis ulcerative, or active hemorrhage in unresected tumor, or other conditions that may cause gastrointestinal hemorrhage or perforation as determined by the investigator;
  • Unresolved toxicities higher than CTCAE Grade 1 caused by any prior anti-cancer treatments, excluding alopecia and ≤ Grade 2 neurotoxicity caused by oxaliplatin;
  • Patients with a known or suspected allergy to the investigational product or drugs of the same class;
  • Pregnant (positive pregnancy test before medication) or breastfeeding women;
  • Drug abuse, medical, psychological, or social conditions may affect patient enrollment and the evaluation of experimental results;
  • Having other untreated or concomitant tumors, except cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors. Patients can be enrolled if the tumor has been radically resected and there is no evidence of disease for more than 3 years. Treatment for all other tumors must have been completed at least 3 years prior to enrollment;
  • Patients considered by the investigator to be inappropriate for enrollment in this study.

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

  • Chinese PLA General Hospital

    Beijing

    Ru Jia, +8613811721720, ashleyjr@163.com

    Guanghai Dai

    Recruiting

Other trials in China

About this study

Official title: Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer: a Prospective, Randomized Controlled Clinical Trial

This study is designed to explore the efficacy and safety of surufatinib combined with camrelizumab and AS (nab-paclitaxel and S-1) as first-line treatment compared with AG (nab-paclitaxel and gemcitabine) in unresectable advanced or metastatic pancreatic cancer.

Read the detailed description

For patients with advanced pancreatic cancer (APC), chemotherapy is still the predominant treatment. The first-line regimens include AG (nab-paclitaxel and gemcitabine) and FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin). AS (nab-paclitaxel and S-1) was explored and widely used in China especially for those with poor performance. This prospective, randomized controlled phase 1b/2 clinical study was designed to explore the efficacy and safety of surufatinib combined with camrelizumab and AS as first-line treatment compared with AG in APC.

Being tested
surufatinib + camrelizumab + nab-paclitaxel + S-1, nab-paclitaxel + gemcitabine
Medical subject headings
Pancreatic Neoplasms

What participants receive

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

  • surufatinib + camrelizumab + nab-paclitaxel + S-1Drug

    phase 1b: surufatinib 200 or 250 mg/d, qd po; camrelizumab: 200mg, I.V., D1, Q3W; nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; S-1: 40mg bid, D1-14, Q3W; DLTs will be evaluated at first cycle;

    phase 2: surufatinib RP2D + camrelizumab + nab-paclitaxel + S-1 when evaluated SD, PR or CR after 4-6 cycles (according to RECIST 1.1), followed by maintenance treatment: surufatinib + camrelizumab + S-1

  • nab-paclitaxel + gemcitabineDrug

    nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W

Study groups in NCT05218889
Study groupRoleWhat they receive
surufatinib + camrelizumab + nab-paclitaxel + S-1ExperimentalNot described
Receives: Drug: surufatinib + camrelizumab + nab-paclitaxel + S-1
nab-paclitaxel + gemcitabineActive comparatorNot described
Receives: Drug: nab-paclitaxel + gemcitabine

What is being measured

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

  1. DLTs

    Dose-limiting toxicities will be evaluated by the investigators at the first cycle in Ib phase

    Measured: Up to 21 days after the first dose of surufatinib

  2. RP2D

    The RP2D is defined as the dose level of surufatinib chosen by the investigators for the phase II experimental arm, based on DLTs

    Measured: Up to 21 days after the first dose of surufatinib

  3. ORR

    The proportion of patients with a confirmed complete response or partial response

    Measured: up to 3 years

Secondary outcomes (6)

  1. PFS

    PFS is defined as the time (in days) from randomization to disease progression or death.

    Measured: up to 3 years

  2. DCR

    The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD)

    Measured: up to 3 years

  3. OS

    OS is defined as the time from randomization to death from any cause.

    Measured: up to 3 years

  4. DOR

    DOR is defined as the time from the first documented CR or PR to disease progression or death.

    Measured: up to 3 years

  5. TTR

    TTR is defined as the time from randomization to achieving the first objective response.

    Measured: up to 3 years

  6. Safety and tolerability by incidence, severity and outcome of adverse events

    Safety and tolerance will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0

    Measured: up to 3 years

Timeline

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

  1. First posted1 Feb 2022
  2. Study start4 Aug 2021
  3. Primary completion16 Dec 2024
  4. Study completionJun 2025 (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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05218889
Sponsor's protocol ID
HMPL-012-SPRING-P101
Status last verified
Dec 2024
First submitted
20 Jan 2022
Last updated
31 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Jia R, Si HY, Fan MJ, Zhang N, Deng GC, Liu FF, Han L, Gou MM, Tan ZL, Zhang X, Wang YR, Shi Y, Zhang YY, Jia YS, Wang YQ, Han QL, Wang ZK, Dai GH. First-line treatment with chemotherapy, surufatinib (an angio-immuno kinase inhibitor), and camrelizumab (an anti-PD-1 antibody) for locally advanced or metastatic pancreatic ductal adenocarcinoma: a phase Ib/II randomized study. Signal Transduct Target Ther. 2025 Oct 13;10(1):339. doi: 10.1038/s41392-025-02441-2.

    PubMed 41077611

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing surufatinib + camrelizumab + nab-paclitaxel + S-1 and nab-paclitaxel + gemcitabine in people with Pancreatic Cancer and PDAC - Pancreatic Ductal Adenocarcinoma, run by Chinese PLA General Hospital 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 11 inclusion and 31 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 31 Dec 2024. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLTs (time frame: Up to 21 days after the first dose of surufatinib). The study lists 3 primary outcomes in all. 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 NCT05218889, 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 31 Dec 2024.

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