The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients

NCT05168527 | Unknown Phase 2 DMC

• 1 other identifier: HMPL-013-NG
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the safety and effectiveness of Fruquintinib combined with Albumin Paclitaxel and Gemcitabine on pancreatic cancer patients with liver metastases. Plan to enrollment 30 patients.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Safety and Effectiveness; TKI; Chemotherapy

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  through study completion, an average of 1 year

Secondary Outcomes (4)

• PFS

  through study completion, an average of 1 year

• DCR

  through study completion, an average of 1 year

• OS

  through study completion, an average of 1 year

• DOR

  through study completion, an average of 1 year

Study Arms (1)

experimental group

EXPERIMENTAL

This is an opened single-arm phase 2 study， the study drug includes Fruquintinib combine with Paclitaxel Injection and Gemcitabine.

Drug: Fruquintinib,Albumin Paclitaxel,Gemcitabine

Interventions

Fruquintinib,Albumin Paclitaxel,Gemcitabine DRUG

The study will mainly explore the safety and tolerability of fixed-dose level of Fruquintinib (4 mg, continuous medication for 3 weeks and withdrawal for 1 week) combined with fixed-dose level of albumin paclitaxel and gemcitabine. The fixed dose of Fruquintinib is 4 mg, with a treatment cycle every 28 days. A 28-day observation window was used to explore the side effects of fruquintinib in the combined treatment of pancreatic cancer patients with liver metastases. Evaluable patients will be assessed for DLT within 28 days after the first administration of the study drug. The 24 patients enrolled in the follow-up group will mainly evaluate the initial efficacy of furquintinib combined with albumin paclitaxel and gemcitabine as the first-line standard treatment for patients with metastatic pancreatic cancer.

experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18 years old;
• Pancreatic cancer was confirmed by pathology or cytology;
• Liver-metastatic confirmed by pathology or clinical imaging;
• Newly treated patients who have not received any systemic treatment for pancreatic cancer are allowed to enter the group for patients who have previously used fluorouracils (excluding gemcitabine and or taxanes) as adjuvant treatments for recurrence;
• ECOG score of preoperative physical condition was 0-1;
• Expected survival time ≥3months;
• There is at least one measurable lesion under CT evaluation according to the RECIST 1.1 standard,;
• The patient has sufficient hematological function (not receiving blood, platelet transfusion or growth factor supportive therapy within 14 days before the start of the study treatment), determined according to the following laboratory test values:
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
• Platelets ≥ 100 × 109/L;
• Hemoglobin ≥ 9.0 g/dL;
• The patient has sufficient liver and kidney function, which is determined according to the following laboratory test values:
• Serum creatinine ≤ 1.5 × ULN;
• If serum creatinine\>1.5 × ULN, creatinine clearance rate ≥50ml/min;
• Alanine aminotransferase (AST) and aspartate aminotransferase (ALT) in non-liver metastatic lesions ≤ 2.5 × ULN, and AST and ALT ≤ 5.0 × ULN in liver metastatic lesions;

You may not qualify if:

• Received chemotherapy within 14 days before entering the study.
• Received VEGFR signaling pathway therapy or other anti-cancer therapy within 14 days before enrollment.
• Received radiotherapy within 14 days before enrollment, and received chest radiotherapy within 28 days before enrollment.
• Active central nervous system involvement is known.
• Oral anticoagulant is being used, or an inhibitor or inducer of potent cytochrome oxidase 3A4 (CYP3A4) is being used (see Appendix 1 for details). Allow the use of subcutaneous anticoagulants.
• Patients who have participated in clinical trials of reagents or new drugs under investigation within 28 days before the first treatment administration (phase I-IV clinical trials).
• Adverse reactions caused by previous anti-tumor treatments did not recover to grade 1 or below (hair loss and peripheral neuropathy did not recover to grade 2 or below).
• Active infection or unexplained fever\> 38.5°C occurred within 2 weeks before the first administration (according to the judgment of the investigator, the subject can be included in the group for fever caused by the tumor).
• Various chronic active infections, such as hepatitis B virus (evidence of hepatitis activity such as HBV-DNA ≥104 copies/ml or 2000IU/ml), hepatitis C and HIV.
• Patients with elevated serum troponin T or I (above the normal limit specified by the research center).
• Pregnant or lactating (lactating) women, where pregnancy is defined as the state of a woman after conception until the end of pregnancy, and the result of a serum β-human chorionic gonadotropin (β-hCG) laboratory test is confirmed to be positive.
• Any of the following cardiac standards: the average QTcF calculated according to Fridericia's formula during the rest period of the screening period \[QTcF = QT/(RR1/3), RR is the standardized heart rate value, obtained by dividing 60 by the heart rate\]: male\> 450 milliseconds , Female\> 470 milliseconds; any clinically important abnormalities in the rhythm, conduction or morphology of the resting electrocardiogram (ECG) (for example, complete left bundle branch block, third degree heart block, second degree heart block); Congenital long QT syndrome or family history of long QT syndrome.
• According to the investigator's judgment, patients who have not fully recovered after surgery, patients whose wounds are in an active healing stage, patients who underwent major surgery within 28 days before the start of the study, and patients who underwent minor surgery within 14 days before the start of the study.
• Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines , Uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, heart block above II, congestive heart failure (CHF), myocardial infarction in the past 6 months , Unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc.) or lung disease (history of interstitial pneumonia, obstructive lung disease and symptomatic bronchospasm).
• Any other situation that the researcher considers inappropriate to participate in clinical research.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

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MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

HMPL-013

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Xianjun MD Yu, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianjun MD Yu, PhD

CONTACT

+86-18017317266; yuxianjun@fudanpci.org

Si Shi

CONTACT

+86-18121299331; shisi@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Shanghai Pancreatic Cancer Institute

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 23, 2021
• Study Start: September 3, 2021
• Primary Completion: March 2, 2024
• Study Completion: May 31, 2024
• Last Updated: January 14, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)