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

NCT05988372 | Not Yet Recruiting Phase 2

• 1 other identifier: LAPC2023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Locally Advanced Pancreatic Cancer

Keywords

Locally Advanced Pancreatic Cancer; Conversion Therapy

Outcome Measures

Primary Outcomes (1)

• R0 Surgical Resection Rate

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

  Up to 2 years

Secondary Outcomes (7)

• Surgical conversion rate

  Up to 2 years

• Objective response rate (ORR)

  Up to 2 years

• Deepness of response (DpR)

  Up to 2 years

• Progression-Free Survival (PFS)

  Up to 2 years

• Disease-free survival (DFS)

  Up to 2 years

Study Arms (2)

Surufatinib + Serplulimab+Albumin-paclitaxel + Gemcitabine

EXPERIMENTAL

enrolled, eligible patients receive Surufatinib, Serplulimab, Gemcitabine and Albumin-paclitaxel

Drug: Surufatinib + Serplulimab+Albumin-paclitaxel + Gemcitabine

Albumin-paclitaxel + Gemcitabine

EXPERIMENTAL

enrolled, eligible patients receive Gemcitabine and Albumin-paclitaxel

Drug: Albumin-paclitaxel + Gemcitabine

Interventions

Surufatinib + Serplulimab+Albumin-paclitaxel + Gemcitabine DRUG

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

Surufatinib + Serplulimab+Albumin-paclitaxel + Gemcitabine

Albumin-paclitaxel + Gemcitabine DRUG

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 + Gemcitabine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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:

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

surufatinib; Gemcitabine

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Kuang Ming, Ph.D

CONTACT

008687755766; kuangm@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: October 23, 2023
• Primary Completion: October 23, 2023
• Study Completion (Estimated): October 23, 2026
• Last Updated: November 1, 2023

Record last verified: 2023-10

Locations

CN (1)