SOX Sequential S-1 in Advanced Biliary Tract Carcinoma（BTC）and Pancreatic Cancer

NCT01811277 | Unknown Phase 2

• 1 other identifier: SOX-S-1 BTC
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Biliary Tract Cancer; Periampullary Adenocarcinoma; Pancreatic Cancer

Keywords

palliative chemotherapy; ORR; PFS; OS; safety; advanced Biliary Tract Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate for SOX sequential S-1

  The primary endpoint is objective response rate,which equals CR+PR.

  1 years

Secondary Outcomes (4)

• Overall Survival

  2 years

• progression free survival

  1 year

• 1 year survival rate

  1 year

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  2 years

Study Arms (1)

SOX sequential S-1

EXPERIMENTAL

4-6 cycles of SOX followed by S-1 monotherapy until disease progression

Drug: SOX sequential S-1

Interventions

SOX sequential S-1 DRUG

4-6 cycles SOX followed by S-1 monotherapy until disease progression S-1: 40\~60mg bid，po, d1\~14 （S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid） oxaliplatin：130mg/m2，iv drip for 2h，d1

Also known as: S-1/oxaliplatin

SOX sequential 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:

• 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；

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Peking University: lead
• Taiho Pharmaceutical Co., Ltd.: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Lin Shen, Prof.

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Shen, Prof.

CONTACT

+86 10 88196175; lin100@medmail.com.cn

Jie Li, Prof.

CONTACT

+86 10 88196561; xiaotong10241@sina.com

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: Head of GI Cancer department

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 14, 2013
• Study Start: July 1, 2010
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 15, 2013

Record last verified: 2010-07

Locations

CN (1)