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Locally Advanced Pancreatic CancerPhase 2NCT05988372

Surufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer (SAGE)

A Phase 2 study testing Surufatinib + Serplulimab+Albumin-paclitaxel + Gemcitabine and Albumin-paclitaxel + Gemcitabine in people with Locally Advanced Pancreatic Cancer, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a Phase II Randomized Controlled PILOT clinical study. The purpose of this study is to explore the efficacy and safety of surufatinib and serplulimab in combination with albumin-paclitaxel and gemcitabine in the conversion therapy for patients with unresectable locally advanced pancreatic cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Locally Advanced Pancreatic Cancer
What is being tested?
Surufatinib + Serplulimab+Albumin-paclitaxel + Gemcitabine and Albumin-paclitaxel + Gemcitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
23 Oct 2023to 23 Oct 2026
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

  • Written informed consent obtained from the patient prior to treatment.
  • Pathologically confirmed unresectable locally advanced pancreatic cancer, received no surgical therapy.
  • Age between 18 and 75 years at the time of study entry.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Measurable or evaluable lesions according to RECIST v1.1 criteria.
  • Life expectancy ≥ 12 weeks.
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  • There are no serious organic diseases of the heart, lungs, brain and other organs.
  • Adequate functioning of the bone marrow and major organs function meeting the following criteria:
  • White blood cell count ≥ 4 × 109/L, Neutrophil count ≥ 1.5 × 109/L, Platelets count ≥ 100 × 109/L,Hemoglobin ≥ 90 g/L.
  • Normal coagulation function, without active bleeding or thrombotic diseases: INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN.
  • Liver function: Total serum bilirubin ≤ 1.5 ×ULN, Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 3 × ULN, Obstructive Jaundice with total serum bilirub ≤ 1.5 x ULN after internal/ external drainage.
  • Kidney function: Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min.
  • Cardiac function:left ventricular ejection fraction (LVEF) of 50%≥ on 2D cardiac ultrasound.
  • Male or female patients of potential for childbearing who voluntarily used effective contraceptive methods such as double-barrier contraception, condoms, oral or injection avoidance or pregnancy medications, IUDs, etc during the study period and within 6 months of the last study medication . All female patients will be considered fertile unless the female patient is naturally menopausal.

Who cannot join

  • Participants diagnosed pancreatic cancer with distant metastases.
  • Participation in other antineoplastic drug clinical trials within 4 weeks prior to enrollment;
  • Previous systemic antitumor therapy (chemotherapy, radiation, targeted or immunoth, etc.).
  • Diagnosis of any second malignancy, except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix uteri.
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • Active or prior documented autoimmune or inflammatory disorders.
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  • Participants are being treated with immunosuppressants, or systemic or absorbable topical hormones for immunosuppressive purposes (dose> 10 mg/day prednisone or other equivalent hormones) , and the use is still continued within 2 weeks before enrollment.
  • Have undergone any surgery (other than biopsy) or invasive treatment or manipulation within 4 weeks prior to enrollment and the surgical incision has not healed completely (except intravenous catheterization, puncture drainage, internal or external drainage of obstructive jaundice, etc.)
  • Participants with abnormal thyroid function who were unable to maintain thyroid function within the normal range with medical treatment.
  • Hypertension that cannot be controlled in the presence of optimal treatment is defined as systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg.
  • Urinary routine showed that urinary protein ≥2+, and 24-hour urinary protein>1.0g.
  • Participantst currently has any disease or condition that affects the absorption of the drug, or the participants cannot take sulfatinib orally
  • participants with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding>30 mL within 3 months with hematemesis, melena, hematochezia), hemoptysis (fresh blood>5 mL within 4 weeks); Patients with history of hereditary or acquired bleeding or coagulation dysfunction, with clinically significant bleeding symptoms or definite bleeding tendency within 3 months, such as gastrointestinal bleeding and hemorrhagic gastric ulcer.
  • Cardiovascular disease of significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina, or coronary bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) grade > 2 for congestive heart failure; ventricular arrhythmias requiring drug therapy; Electrocardiogram (ECG) showing QT interval ≥480 ms;
  • Severe infection that is active or uncontrolled:
  • Inherited or acquired immunodeficiency disease,
  • Known clinically significant history of liver disease, including viral hepatitis [known hepatitis B virus (HBV) carriers must exclude active HBV infection , HBV DNA positive (>1×104 copies/mL or >2000 IU/ml)];
  • known hepatitis C virus infection (HCV) and positive HCV RNA (>1×103 copies/ml) or other hepatitis, cirrhosis.
  • Pregnant or lactating women or participants with family planning during the trial period.
  • Participants have a known history of psychotropic substance abuse, alcoholism, or drug abuse.
  • The investigator believes that the participant has any clinical or laboratory abnormalities or other reasons that are unsuitable for this clinical study.

Trial locations and contacts

1 site in 1 country.

Kuang Ming, Ph.D contact

008687755766 ext. 8576

kuangm@mail.sysu.edu.cn

China1 site

  • First Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510080

    Kuang Ming, 008687755766 ext. 8576, kuangm@mail.sysu.edu.cn

Other trials in China

About this study

Official title: Surufatinib and Serplulimab Combined With AG Regimen Compare With AG Regimen as Conversion Therapy for Patients With Locally Advanced Pancreatic Cancer : a Phase II Randomized Controlled PILOT Study (SAGE)

This is a Phase II Randomized Controlled PILOT clinical study. The purpose of this study is to explore the efficacy and safety of surufatinib and serplulimab in combination with albumin-paclitaxel and gemcitabine in the conversion therapy for patients with unresectable locally advanced pancreatic cancer. Furthermore, it compares the efficacy of surufatinib and serplulimab in combination with albumin-paclitaxel and gemcitabine to the albumin-paclitaxel and gemcitabine regimen in the conversion therapy for patients with unresectable locally advanced pancreatic cancer.

Read the detailed description

A total of 50 participants are expected to be enrolled in this study; 25 will receive the surufatinib and serplulimab in conjunction with albumin-paclitaxel and gemcitabine regimen and 25 will receive the AG regimen. The participants who have been enrolled will initially undergo two cycles of albumin-paclitaxel and gemcitabine induction chemotherapy. The researcher will assess the patients' efficacy based on their imaging results after the second cycle. Patients with PD will be excluded from this trial, and patients with SD, PR, or CR will be enrolled. Patients will be randomly chosen to receive either the AG regimen for 2-4 cycles or the surufatinib combined with serplulimab and AG regimen for 2-4 cycles. Every two cycles, the researcher assessed the effectiveness of the patients' treatments and the potential for R0 resection. Then, patients with PD were removed from the group, those who could be operated were enrolled for surgical resection, and those without PD and unable to undergo surgery were finished with a total of 6 cycles of either the AG regimen chemotherapy or surufatinib combined with serplulimab and the AG regimen chemotherapy. Within 12 weeks of surgery, patients underwent 0-2 cycles of chemotherapy with the AG regimen or surufatinib combined with serplulimab and AG regimen, totaling 6 cycles of postoperative chemotherapy. Then patients of AG group will enter follow up stage. Patients with R0 resection will accept surufatinib in combination with serplulimab maintenance for no longer than 12 cycles after surgery, or until intolerability, progressive disease, death, or other criteria for study treatment discontinuation specified in the protocol, whichever comes first. Patients who have not progressed and are unable to undergo surgery, or who accepted R1 or R2 resection, after six cycles of the surufatinib combination with serplulimab and AG regimen, will receive sulfatinib combined with serplulimab maintenance therapy for a maximum of 29 cycles, or until intolerance, disease progression, death, or other criteria specified in the study protocol were met.

Being tested
Surufatinib + Serplulimab+Albumin-paclitaxel + Gemcitabine, Albumin-paclitaxel + Gemcitabine
Keywords
Locally Advanced Pancreatic Cancer, Conversion Therapy

What participants receive

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

  • Surufatinib + Serplulimab+Albumin-paclitaxel + GemcitabineDrug

    Surufatinib:250mg orally once a day for 3 weeks(3 weeks 1 cycle) Serplulimab:4.5mg/Kg by intravenous infusions on day1 every 3 weeks Albumin-paclitaxel:125mg/m2 by intravenous infusions on day1 and 8 every 3 weeks Gemcitabine:1000mg/m2 by intravenous infusions on day1 and 8 every 3 weeks

  • Albumin-paclitaxel + GemcitabineDrug

    Albumin-paclitaxel:125mg/m2 by intravenous infusions on day1 and 8 every 3 weeks Gemcitabine:1000mg/m2 by intravenous infusions on day1 and 8 every 3 weeks

Study groups in NCT05988372
Study groupRoleWhat they receive
Surufatinib + Serplulimab+Albumin-paclitaxel + GemcitabineExperimentalenrolled, eligible patients receive Surufatinib, Serplulimab, Gemcitabine and Albumin-paclitaxel
Receives: Drug: Surufatinib + Serplulimab+Albumin-paclitaxel + Gemcitabine
Albumin-paclitaxel + GemcitabineExperimentalenrolled, eligible patients receive Gemcitabine and Albumin-paclitaxel
Receives: Drug: Albumin-paclitaxel + Gemcitabine

What is being measured

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

  1. R0 Surgical Resection Rate

    Proportion of patients with negative microscopic margins (no tumor cell remains)

    Measured: Up to 2 years

Secondary outcomes (7)

  1. Surgical conversion rate

    Surgical conversion rate: the proportion of patients with successful conversion and surgical resection in all patients, surgical conversion rate =(number of patients with successful conversion and surgical resection/total number of patients) ×100%.

    Measured: Up to 2 years

  2. Objective response rate (ORR)

    ORR is defined as the percentage of patients who have achieved complete response (CR) or partial response (PR), as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria

    Measured: Up to 2 years

  3. Deepness of response (DpR)

    DpR is defined as the percentage of maximal tumor reduction from baseline of a target lesion.

    Measured: Up to 2 years

  4. Progression-Free Survival (PFS)

    PFS is defined as the time from the first dose of administration to progression or death

    Measured: Up to 2 years

  5. Disease-free survival (DFS)

    DFS is defined as the time interval between the date of enrollment and the date of the first documented evidence of relapse after radical resection at any site or death related to cancer

    Measured: Up to 2 years

  6. Over Survival (OS)

    OS is defined as the time from first treatment to death, regardless of disease recurrence

    Measured: Up to 2 years

  7. Quality of Life (QOL)

    Acording the EORTC QLQ-C30.

    Measured: Up to 2 years

Timeline

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

  1. First posted14 Aug 2023
  2. Study start23 Oct 2023 (estimated)
  3. Primary completion23 Oct 2023 (estimated)
  4. Study completion23 Oct 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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05988372
Sponsor's protocol ID
LAPC2023
Status last verified
Oct 2023
First submitted
4 Aug 2023
Last updated
1 Nov 2023
Results posted
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 + Serplulimab+Albumin-paclitaxel + Gemcitabine and Albumin-paclitaxel + Gemcitabine in people with Locally Advanced Pancreatic Cancer, 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 14 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 1 Nov 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kuang Ming, Ph.D (008687755766 ext. 8576, kuangm@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 Surgical Resection Rate (time frame: Up to 2 years). 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 NCT05988372.

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 1 Nov 2023.

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