Actively Recruiting
Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer
Led by InnoPharmax Inc. · Updated on 2025-04-30
180
Participants Needed
5
Research Sites
244 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective are: To assess the safety and tolerability of the combination of D07001-softgel capsules and Xeloda/TS-1. To evaluate the efficacy of the combination of D07001-softgel capsules and Xeloda/TS-1, as assessed by disease control rate (DCR).
CONDITIONS
Official Title
Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 years or older (20 years or older in Taiwan)
- Diagnosed with unresectable metastatic or locally advanced biliary tract cancer including cholangiocarcinoma, gallbladder cancer, or ampullary carcinoma
- Have failed first-line gemcitabine and cisplatin chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy greater than 12 weeks
- Adequate bone marrow function: ANC ≥1500 cells/mm3, platelet count ≥100,000 cells/mm3, hemoglobin ≥9 g/dL
- Adequate liver function: AST and ALT ≤2.5 times upper limit of normal (ULN), or ≤5 times ULN with liver metastases; total bilirubin ≤1.5 times ULN; albumin ≥3.0 g/dL; INR <1.5
- Adequate kidney function: serum creatinine ≤1.5 times ULN; creatinine clearance or eGFR ≥50 mL/min
- Negative pregnancy test and not breastfeeding for women of childbearing potential
- Use of medically acceptable contraception methods during and for 1 month after study participation
- Signed informed consent prior to study procedures
- Willingness to follow the study visit schedule and requirements
- No more than 60 days since last chemotherapy or chemoradiotherapy
- No chemotherapy since first-line treatment
You will not qualify if you...
- Prior chemotherapy other than first-line gemcitabine and cisplatin for biliary tract cancer, except certain fluoropyrimidine-based adjuvant therapies
- Active malignancy other than biliary tract cancer within past 2 years, except treated nonmelanoma skin cancer or carcinoma in situ of uterine cervix
- Prior discontinuation of gemcitabine due to serious toxicity or hypersensitivity
- Known allergy or hypersensitivity to study drugs or related compounds
- Prior severe reaction to fluoropyrimidine chemotherapy
- Treatment with brivudine, sorivudine, or related drugs within 28 days before enrollment
- Current treatment with flucytosine
- Residual toxicity from prior therapy greater than Grade 1 (except certain neuropathy or alopecia)
- Gastrointestinal disorders impeding oral drug absorption
- Known brain or leptomeningeal metastases
- Major surgery or definitive radiation within 28 days before enrollment
- Any active condition preventing compliance with the protocol
- Significant cardiovascular disease or uncontrolled arrhythmia
- Documented cerebrovascular disease unless well controlled
- Uncontrolled seizure disorder
- Receipt of investigational agent within 28 days before enrollment
- Active uncontrolled infections
- HIV infection
- Hepatitis B or C infection with specified viral loads
- Recent live attenuated vaccine within 4 weeks before screening
- History of drug or alcohol abuse within last year
- Other serious medical conditions that preclude safe participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 807
Actively Recruiting
2
China Medical University Hospital
Taichung, Taiwan, 404
Actively Recruiting
3
National Taiwan University Cancer Center
Taipei, Taiwan
Actively Recruiting
4
National Taiwan University Hospotal
Taipei, Taiwan
Actively Recruiting
5
Taipei Veterans General Hospital
Taipei, Taiwan
Actively Recruiting
Research Team
Y
Yuyuan Lin
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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