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

NCT05969171 | Recruiting Phase 2

• 1 other identifier: HMPL-012-SH-PC101
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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. 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no disease progression will be enrolled: Arm 1: Surufatinib plus AG chemotherapy (q3w) until disease progression/death/withdrawn; Arm 2: AG chemotherapy (q3w) until disease progression/death/withdrawn; During the treatment period, imaging methods were used to evaluate the tumor status every 6 weeks (±7 days) until disease progression (RECIST 1.1) or death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.

Conditions

Pancreatic Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  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

  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

  Overall survival (OS) refers to the duration from the date of enrollment to the date of death due to any cause.

• Disease control rate

  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

Study Arms (2)

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.

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.

Drug: Nab-paclitaxel, gemcitabine

Interventions

Surufatinib, gemcitabine, nab-paclitaxel DRUG

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.

Surufatinib in combination with gemcitabine and nab-paclitaxel

Nab-paclitaxel, gemcitabine DRUG

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.

Nab-paclitaxel combined with 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:

• 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);
• 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;

You may not qualify if:

• 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;
• 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;
• 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.;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University ShangHai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Interventions

surufatinib; Gemcitabine; 130-nm albumin-bound paclitaxel

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jin Xu

  180 1731 7267

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jin Xu

CONTACT

180 1731 7267; xujin@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Pancreatic Surgery, Fudan University ShangHai Cancer Center

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: August 1, 2023
• Study Start: December 5, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)