Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-03-02 @ 1:23 AM
Study NCT ID:
NCT05138159
Status:
UNKNOWN
Last Update Posted:
2021-11-30
First Post:
2021-11-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Donafenib Plus S-1 in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Nab-paclitaxel Plus Gemcitabine Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000710249', 'term': 'donafenib'}, {'id': 'C079198', 'term': 'S 1 (combination)'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-17', 'studyFirstSubmitDate': '2021-11-17', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Progression Free Survival', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Overall Response Rate', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Incidence of Adverse Events', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Metastatic Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe efficacy and safety data will be assessed through OS, ORR, DCR, PFS,TTP and adverse effects as graded by NCI CTC-AE 5.0.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Informed consent and willing to complete the study according to the protocol.\n* Age ≥ 18 years and ≤ 75 years, and there is no limit on the gender\n* ECOG performance scale 0-1;\n* Diagnosed as pancreatic adenocarcinoma by histology and cytology;\n* 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)；\n* Baseline blood routine and biochemical indexes meet the following criteria:\n\n 1. Blood routine examination criteria must be met: (no blood transfusion within 14 days)\n\n 1. HB≥90g/L；\n 2. ANC≥1.5×109/L；\n 3. PLT≥100×109/L.\n 2. Biochemical tests are subject to the following criteria:\n\n 1. BIL \\<1.25xULN ；\n 2. ALT and AST\\<2.5ULN；\n 3. Serum creatinine. Less than 1.5 times the upper limit of normal value, Endogenous creatinine clearance\\>60ml/min ( Cockcroft-Gault formula).\n 4. Albumin≥28g/L.\n 3. Blood coagulation indexes are subject to the following criteria:\n\n 1. Prothrombin time (PT) and international normalized ratio (INR) ≤1.5 × ULN;\n 2. Activated partial thromboplastin time（APTT）≤1.5 × ULN.\n* According to the standard of RECIST 1.1, there is at least one imaging measurable lesion;\n* Life expectancy ≥ 3 months;\n* Patients and their families were willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n* 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);\n* Medical conditions that affect absorption, distribution, metabolism, or clearance of the study drug (e.g., severe vomiting, chronic diarrhea, intestinal obstruction, absorption disorders, etc.);\n* Patients with brain metastases or pial metastases;\n* Patients with a clear past history of neurological or psychiatric disorders, including epilepsy or dementia;\n* 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;\n* 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;\n* The patient had a history of organ transplantation;\n* Concurrent administration of drugs that may prolong QTc and/or induce Tdp;\n* Patients also take drugs that affect drug metabolism;\n* HIV infection or acute or chronic viral hepatitis (hbSAG positive, HBV-DNA load ≥500IU/ml and/or HCV antibody positive);\n* Excluded patients with serious cardiovascular disease, including grade ≥II cardiac dysfunction (NYHA criteria);\n* Patients with severe gastrointestinal dysfunction (bleeding, infection, obstruction, or diarrhea greater than grade 1) were excluded;\n* Patients with abnormal coagulation function, bleeding tendency, or receiving thrombolytic or anticoagulant therapy were excluded;\n* Patients with a severe arterial thromboembolism event within 6 months were excluded;\n* Excluding women who are pregnant or breast-feeding."}, 'identificationModule': {'nctId': 'NCT05138159', 'briefTitle': 'A Study of Donafenib Plus S-1 in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Nab-paclitaxel Plus Gemcitabine Regimen', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'A Prospective, Phase II, Single-arm Study to Evaluate The Safety and Efficacy of Donafenib Plus S-1 in Treating Patients With Metastatic Pancreatic Cancer After Chemotherapy With Nab-paclitaxel Plus Gemcitabine Regimen', 'orgStudyIdInfo': {'id': 'PDAC-ZPS-S'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Donafenib + S-1', 'description': '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.', 'interventionNames': ['Drug: Donafenib', 'Drug: S1']}], 'interventions': [{'name': 'Donafenib', 'type': 'DRUG', 'description': 'Donafenib: 200mg po bid.', 'armGroupLabels': ['Experimental: Donafenib + S-1']}, {'name': 'S1', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Experimental: Donafenib + S-1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Yu Xian-Jun, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'yuxianjun@fudanpci.org', 'phone': '+86-21-6417-5590'}], 'facility': 'Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}