A Study Of Donafenib Plus S-1 In Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Nab-paclitaxel Plus Gemcitabine Regimen

Study Overview

A Study of Donafenib Plus S-1 in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Nab-paclitaxel Plus Gemcitabine Regimen

This is a single arm, open label Phase II clinical trial to evaluate the efficacy and safety of donafenib combined with S-1 in treating Patients with metastatic pancreatic cancer after chemotherapy with Nab-paclitaxel plus gemcitabine regimen.

While NG ( Nab-paclitaxel + gemcitabine) is one of the preferred first-line chemotherapy for metastatic pancreatic cancer, we have to investigate possible therapeutic options after NG regimen. In this single arm, open-label clinical trial, metastatic pancreatic cancer patients will be received donafenib and S-1. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel therapeutic. The efficacy and safety data will be assessed through OS, ORR, DCR, PFS,TTP and adverse effects as graded by NCI CTC-AE 5.0.

Metastatic Pancreatic Cancer

DRUG: Donafenib
DRUG: S1

PDAC-ZPS-S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-11-17	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-11-17
First Submitted that Met QC Criteria 2021-11-17	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-11-30
First Posted (ACTUAL) 2021-11-30	Results First Posted N/A	Last Verified 2021-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Experimental: Donafenib + S-1 Donafenib: 200mg po bid； S-1 capsule: According to the body surface area <1.25m2 40mg/d, 1.25 ~ 1.5 m2 50 mg/d, > 1.5m2 60mg/d po bid, taking 14 days, stopping for 7 days, 21 days for 1 cycle.	DRUG: Donafenib Donafenib: 200mg po bid. DRUG: S1 S-1 capsule: According to the body surface area <1.25m2 40mg/d, 1.25 ~ 1.5 m2 50 mg/d, > 1.5m2 60mg/d po bid, taking 14 days, stopping for 7 days, 21 days for 1 cycle.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Experimental: Donafenib + S-1

Donafenib: 200mg po bid； S-1 capsule: According to the body surface area <1.25m2 40mg/d, 1.25 ~ 1.5 m2 50 mg/d, > 1.5m2 60mg/d po bid, taking 14 days, stopping for 7 days, 21 days for 1 cycle.

DRUG: Donafenib

Donafenib: 200mg po bid.

DRUG: S1

S-1 capsule: According to the body surface area <1.25m2 40mg/d, 1.25 ~ 1.5 m2 50 mg/d, > 1.5m2 60mg/d po bid, taking 14 days, stopping for 7 days, 21 days for 1 cycle.

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival	To evaluate the overall survival of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen after treatment with Donafenib combined with S-1.	through study completion, an average of 1 year

Secondary Outcome Measures	Measure Description	Time Frame
Progression Free Survival	To investigate the progression-free survival (PFS) of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen after treatment with Donafenib combined with S-1.	through study completion, an average of 1 year
Overall Response Rate	To evaluate the overall response rate of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen after treatment with Donafenib combined with S-1.	through study completion, an average of 1 year
Incidence of Adverse Events	Adverse events of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen after treatment with Donafenib plus S-1.	through study completion, an average of 1 year

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Informed consent and willing to complete the study according to the protocol.
Age ≥ 18 years and ≤ 75 years, and there is no limit on the gender
ECOG performance scale 0-1;
Diagnosed as pancreatic adenocarcinoma by histology and cytology;
Treatment of patients with advanced metastatic pancreatic cancer who have failed with NG (Nab-paclitaxel + gemcitabine) regimen(The disease progresses during the course of treatment or within 6 months after the end of treatment, with clear imaging evidence; this does not include patients with intolerable toxicity)；
Baseline blood routine and biochemical indexes meet the following criteria:

According to the standard of RECIST 1.1, there is at least one imaging measurable lesion;
Life expectancy ≥ 3 months;
Patients and their families were willing to cooperate with follow-up.

Diagnosis of malignant diseases other than pancreatic cancer within 5 years prior to first administration (excluding cured skin basal cell carcinoma, squamous carcinoma of the skin, and/or resected carcinoma in situ);
Medical conditions that affect absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.);
Patients with brain metastases or pial metastases;
Patients with a clear past history of neurological or psychiatric disorders, including epilepsy or dementia;
Comorbidities (e.g., severe or uncontrolled hypertension, severe diabetes, and/or thyroid disease) that, in the investigator's judgment, seriously endanger patients' safety or prevent them from completing the study;
The patient was currently participating in an interventional clinical study or had been treated with another study drug or study device in the 4 weeks prior to initial dosing;
The patient had a history of organ transplantation;
Concurrent administration of drugs that may prolong QTc and/or induce Tdp;
Patients also take drugs that affect drug metabolism;
HIV infection or acute or chronic viral hepatitis (hbSAG positive, HBV-DNA load ≥500IU/ml and/or HCV antibody positive);
Excluded patients with serious cardiovascular disease, including grade ≥II cardiac dysfunction (NYHA criteria);
Patients with severe gastrointestinal dysfunction (bleeding, infection, obstruction, or diarrhea greater than grade 1) were excluded;
Patients with abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy were excluded;
Patients with a severe arterial thromboembolism event within 6 months were excluded;
Excluding women who are pregnant or breast-feeding.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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