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New treatment option for Biliary Tract Cancer
Official title Study of Combination Therapy of D07001-Softgel Capsules and Xeloda/TS-1 in Subjects With Advanced Biliary Tract Cancer
ClinicalTrials.gov ID: NCT05065957
What this study is testing
What is D07001-softgel capsules + Xeloda (or TS-1)?
D07001-softgel capsules + Xeloda (or TS-1) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for biliary tract cancer.
Also referred to as Treatment group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female patients aged 18 years or older at screening (aged 20 years or older in Taiwan)
- Histopathological or cytologic diagnosis of unresectable metastatic or locally advanced BTC (cholangiocarcinoma, gallbladder cancer or ampullary...
- Subject must have failed from first line gemcitabine and cisplatin-based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
- Life expectancy is \>12 weeks
You likely can't join if
- Have prior chemotherapy regimen other than first line gemcitabine and cisplatin-based therapy for unresectable metastatic or locally advanced BTC...
- Diagnosis of active malignancy other than BTC within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix...
- Prior discontinuation of gemcitabine because of pulmonary or hepatic toxicity or hemolytic uremic syndrome (HUS) or hypersensitivity, allergic...
- Known or suspected hypersensitivity to capecitabine, tegafur, gimeracil, oteracil potassium, oxaliplatin or other platinum compounds, leucovorin...
- Prior discontinuation of fluoropyrimidine because of any unexpected or severe reaction.
- Treatment with brivudine, sorivudine, or its chemically-related analogs ≤ 28 days prior to the date of enrollment.
See the full eligibility criteria
- Male or female patients aged 18 years or older at screening (aged 20 years or older in Taiwan)
- Histopathological or cytologic diagnosis of unresectable metastatic or locally advanced BTC (cholangiocarcinoma, gallbladder cancer or ampullary carcinoma)
- Subject must have failed from first line gemcitabine and cisplatin-based chemotherapy
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1
- Life expectancy is \>12 weeks
- Adequate bone marrow function, demonstrated by:
- Absolute neutrophil count (ANC) ≥1,500 cell/mm3
- Platelet count ≥ 100,000 cells/mm3
- Hemoglobin ≥ 9 g/dL
- Adequate liver function, demonstrated by:
- Aspartate transaminase (AST) and alanine transaminase (ALT) ≤2.5 x upper limit of normal (ULN), or ≤5.0 x ULN in the case of liver metastases
- Total bilirubin ≤1.5 x ULN
- Albumin ≥3.0 g/dL
- International normalized ratio (INR) \<1.5
- Adequate renal function, demonstrated by:
- Serum creatinine ≤1.5 x ULN
- Creatinine clearance ≥ 50mL/min calculated by Cockcroft-Gault formula or eGFR ≥ 50mL/min/1.73m2 by 2021 CKD-EPI Creatinine Equation
- A negative serum pregnancy test at screening and is not breastfeeding in woman of childbearing potential
- Women of childbearing potential or male people must use a medically acceptable form of contraception as 2 barrier methods (e.g., combination of condom, diaphragm, or intrauterine device), hormonal contraception...
- Provision of a signed and dated written Informed Consent Form (ICF) prior to any study specific procedures
- Subject is willing to comply with protocol-required visit schedule and visit requirements
- No more than 60 days have elapsed between completion of the prior line of chemotherapy or CCRT and enrollment
- Subject has not received other chemotherapy since first-line treatment
- Have prior chemotherapy regimen other than first line gemcitabine and cisplatin-based therapy for unresectable metastatic or locally advanced BTC Note: prior fluoropyrimidine base (including capecitabine, carmofur...
- Diagnosis of active malignancy other than BTC within the past 2 years, except nonmelanoma skin carcinoma and carcinoma-in-situ of uterine cervix treated with curative intent
- Prior discontinuation of gemcitabine because of pulmonary or hepatic toxicity or hemolytic uremic syndrome (HUS) or hypersensitivity, allergic reaction, or intolerance
- Known or suspected hypersensitivity to capecitabine, tegafur, gimeracil, oteracil potassium, oxaliplatin or other platinum compounds, leucovorin products, folic acid or folinic acid, 5-fluorouracil or their excipients.
- Prior discontinuation of fluoropyrimidine because of any unexpected or severe reaction.
- Treatment with brivudine, sorivudine, or its chemically-related analogs ≤ 28 days prior to the date of enrollment.
- Under flucytosine treatment.
- Residual toxicity from prior chemotherapy or CCRT that is Grade ≥2 (residual Grade 2 neuropathy and alopecia are permitted)
- Any GI disorder which would significantly impede absorption of an oral agent
- Known brain or leptomeningeal metastases
- Major surgery or definitive ablation-intent (excluding palliative radiotherapy for bone metastasis) radiation therapy within the past 28 days
- Any active disease or condition that would not permit compliance with the protocol
- Clinically significant cardiovascular disease (e.g., uncontrolled hypertension, unstable angina, congestive heart failure, or New York Heart Association [NYHA] Grade 2 or greater), or uncontrolled serious cardiac...
- Have documented cerebrovascular disease. people with the disease may be excluded, but if the investigator assesses that they are asymptomatic or well controlled could be enrolled.
- Have a seizure disorder not controlled on medication (based on decision of Investigator)
- Received an investigational agent within 28 days of enrollment
- Have an uncontrolled active viral, bacterial, or systemic fungal infection
- Known human immunodeficiency virus (HIV) infection
- Have HBsAg (hepatitis B surface antigen) positive with HBV-DNA ≥2000 copies/ml and/or anti-HCV antibody (HCV) positive with HCV-RNA positive.
- Received yellow fever vaccine or other live attenuated vaccine(s) within the 4 weeks prior to screening
- History of drug or alcohol abuse within last year
- Have any other serious medical condition that, in the Investigator's medical opinion, would preclude safe participation in, and compliance with, a clinical trial
The study team makes the final eligibility decision.
Where it's taking place
- Kaohsiung City, Taiwan
- Taichung, Taiwan
- Taipei, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kaohsiung City, Taiwan; Taichung, Taiwan; Taipei, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.