Pancreatic Cancer Clinical Trial
Official title:
Phase II Exploratory Study of S-1 Combined With Oxaliplatin Sequential S-1 Single-agent First-line Treatment of Unresectable Metastatic or Locally Advanced Biliary System, Periampullary Cancer and Pancreatic Cancer
This is an exploratory, single-armed, open label study on the efficacy and safety of sequential S-1 therapy after SOX in unresectable metastatic or locally advanced biliary system or periampullary cancer or pancreatic cancer patients. The primary endpoint is Objective response rate and secondary endpoint is progression free survival , overall survival ,1 year survival rate and safety.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Written Informed consent - Male or female patients >=18 years old - Histologically or cytologically confirmed diagnosis of adenocarcinoma - No previous treatment is allowed including chemotherapy, radiotherapy,immunotherapy or others. - In case the patient received adjuvant therapy before, enrollment is allowed if the adjuvant therapy does not contain L-OHP or S-1 and at the same time, the last day of chemotherapy is =180 days before screening. - Target lesion more than 1cm in diameter by enhanced CT or MRI 21 days before enrollment - The laboratory parameter meets the following criteria 7 days before enrollment - Hemoglobin =90g/L - Absolute neutrophil count=1.5×10^9/L, platelets 100×10^9/L; - ALT and AST=2.5 ULN(in case of the patients with liver metastasis,ALT and AST=5.0 ULN) - ALP =2.5 ULN (in case of the patients with liver metastasis,=5.0 ULN) - Total Serum bilirubin =1.5 ULN - Serum creatinine =1.0 ULN - serum albumin(ALB)=30g/L; - can tolerate oral drug administration; - KPS =70 - Estimated survival =90 days - Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of enrollment and must be willing to use adequate methods of contraception during the study and for 30 days after last study durg administration. Exclusion Criteria: - Known sensitivity to 5-HT3 antagonist and hypersensitivity to the other treatment agents including irinotecan, cisplatin and octreotide lar - Any participation in trials simultaneously or 4 weeks before screening. - 15 days prior to enrollment, received a blood transfusion, blood products and hematopoietic growth factors such as G-CSF. - Undergone major surgery = 4 weeks prior to starting study drug or who have not recovered from side effects of such surgery. - Uncontrolled severe diarrhea - Uncontrolled active infection (fever =38 degrees due to infection) - S-1 oral drug administration difficulty due to difficulty swallowing, complete or incomplete digestive tract obstruction, gastrointestinal active bleeding, perforation; - severe hepatopathy including active hepatitis and hepatic cirrhosis, renal dysfunction, severe pulmonary diseases including interstitial pneumonia, pulmonary fibrosis and severe pulmonary emphysema, uncontrolled diabetes, hypertension and other chronic systematic diseases. - Chronic treatment with steroids.(In case of the patients with short-term use of steroids, the enrollment is permitted if the administration is stopped 2 weeks before screening.) - confirmed or suspected CNS metastasis - the history of peripheral nervous system impairment, obvious mental disorder or CNS impairment - clinically significant heart disease, including congestive heart failure, symptomatic coronal heart disease, arrythmia uncontrolled by medication and acute myocardial infarction or cardiac insufficiency within 6 months before screening - Drainage of pleural effusion, peritoneal effusion and pericardial effusion - pregnant women or women in lactation period - Fertile male or women of child-bearing potential refuse to take highly effective methods of birth control - Incidence of other second primary malignant tumors within 5 years, except for cured basal cell carcinoma and cervical carcinoma in situ. - patients of legal incapacity or who have the potential of influence the whole trial due to medical or ethic reasons. - Other patients who are not eligible to the trial under investigators' discretion |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Beijing Cancer Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University | Taiho Pharmaceutical Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective response rate for SOX sequential S-1 | The primary endpoint is objective response rate,which equals CR+PR. | 1 years | No |
Secondary | Overall Survival | OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 3 months till death or lost | 2 years | No |
Secondary | progression free survival | PFS means that from the first dose of treatment drug to disease progression or death or lost, the follow-up visit will be performed every 6 weeks till progression or death or lost | 1 year | No |
Secondary | 1 year survival rate | the follow-up visit of survival will be performed every 3 months till 1 year | 1 year | No |
Secondary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | participants will be followed for the duration of hospital stay, an expected average of 3 weeks | 2 years | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05305001 -
Germline Mutations Associated With Hereditary Pancreatic Cancer in Unselected Patients With Pancreatic Cancer in Mexico
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Recruiting |
NCT05497531 -
Pilot Comparing ctDNA IDV vs. SPV Sample in Pts Undergoing Biopsies for Hepatobiliary and Pancreatic Cancers
|
N/A | |
Recruiting |
NCT06054984 -
TCR-T Cells in the Treatment of Advanced Pancreatic Cancer
|
Early Phase 1 | |
Recruiting |
NCT04927780 -
Perioperative or Adjuvant mFOLFIRINOX for Resectable Pancreatic Cancer
|
Phase 3 | |
Recruiting |
NCT05919537 -
Study of an Anti-HER3 Antibody, HMBD-001, With or Without Chemotherapy in Patients With Solid Tumors Harboring an NRG1 Fusion or HER3 Mutation
|
Phase 1 | |
Terminated |
NCT03140670 -
Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy
|
Phase 2 | |
Terminated |
NCT00529113 -
Study With Gemcitabine and RTA 402 for Patients With Unresectable Pancreatic Cancer
|
Phase 1 | |
Recruiting |
NCT05168527 -
The First Line Treatment of Fruquintinib Combined With Albumin Paclitaxel and Gemcitabine in Pancreatic Cancer Patients
|
Phase 2 | |
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05391126 -
GENOCARE: A Prospective, Randomized Clinical Trial of Genotype-Guided Dosing Versus Usual Care
|
N/A | |
Terminated |
NCT03300921 -
A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer A Phase Ib Pharmacodynamic Study of Neoadjuvant Paricalcitol in Resectable Pancreatic Cancer
|
Phase 1 | |
Completed |
NCT03153410 -
Pilot Study With CY, Pembrolizumab, GVAX, and IMC-CS4 (LY3022855) in Patients With Borderline Resectable Adenocarcinoma of the Pancreas
|
Early Phase 1 | |
Recruiting |
NCT03175224 -
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
|
Phase 2 | |
Recruiting |
NCT05679583 -
Preoperative Stereotactic Body Radiation Therapy in Patients With Resectable Pancreatic Cancer
|
Phase 2 | |
Recruiting |
NCT04183478 -
The Efficacy and Safety of K-001 in the Treatment of Advanced Pancreatic Cancer
|
Phase 2/Phase 3 | |
Terminated |
NCT03600623 -
Folfirinox or Gemcitabine-Nab Paclitaxel Followed by Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer
|
Early Phase 1 | |
Recruiting |
NCT04584008 -
Targeted Agent Evaluation in Digestive Cancers in China Based on Molecular Characteristics
|
N/A | |
Recruiting |
NCT05351983 -
Patient-derived Organoids Drug Screen in Pancreatic Cancer
|
N/A | |
Completed |
NCT04290364 -
Early Palliative Care in Pancreatic Cancer - a Quasi-experimental Study
|