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

NCT05138159 | Unknown Phase 2

• 1 other identifier: PDAC-ZPS-S
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Progression Free Survival

  through study completion, an average of 1 year

• Overall Response Rate

  through study completion, an average of 1 year

• Incidence of Adverse Events

  through study completion, an average of 1 year

Study Arms (1)

Experimental: Donafenib + S-1

EXPERIMENTAL

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; Drug: S1

Interventions

Donafenib DRUG

Donafenib: 200mg po bid.

Experimental: Donafenib + S-1

S1 DRUG

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.

Experimental: Donafenib + S-1

Eligibility Criteria

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

You may qualify if:

• 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:
• Blood routine examination criteria must be met: (no blood transfusion within 14 days)
• HB≥90g/L；
• ANC≥1.5×109/L；
• PLT≥100×109/L.
• Biochemical tests are subject to the following criteria:
• BIL \<1.25xULN ；
• ALT and AST\<2.5ULN；
• Serum creatinine. Less than 1.5 times the upper limit of normal value, Endogenous creatinine clearance\>60ml/min ( Cockcroft-Gault formula).
• Albumin≥28g/L.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University

Shanghai, China

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

donafenib; S 1 (combination)

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: November 30, 2021
• Study Start: December 1, 2021
• Primary Completion: May 30, 2023
• Study Completion: July 30, 2023
• Last Updated: November 30, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)