Fruquintinib as Second-line Treatment for Advanced/Metastatic Biliary Tract Adenocarcinoma
NCT ID: NCT04156958
Last Updated: 2019-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
33 participants
INTERVENTIONAL
2019-12-31
2021-12-31
Brief Summary
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Detailed Description
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The trial is a prospective, multicenter, single-arm design study. Eligible participants with advanced or metastatic biliary tract adenocarcinoma who have failed first-line chemotherapy with gemcitabine, platinum/S-1, and albumin paclitaxel. The study will explore the efficacy and safety of second-line treatment with fruquintinib, and quality of life during treatment. Tumor assessment was performed every 8 weeks as defined by RECIST 1.1. Blood samples will be collected at baseline (before treatment) and 2 weeks after treatment, and cfDNA will be collected for gene detection analysis to evaluate the correlation between different gene mutations and their changes and efficacy.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fruquintinib Arm
Fruquintinib, 5 mg once daily for 21 days, followed by 7 days off (28 days/cycle) treatment until progression, unacceptable toxicity, or withdrawal unless toxicity not relieved after dose adjustment.
Fruquintinib
Fruquintinib will be administered orally at a dose of 5 mg/d, 3 weeks on, 1 week off (4 weeks as a cycle) until progression, unacceptable toxicity, or withdrawal unless toxicity not relieved after dose adjustment.
Interventions
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Fruquintinib
Fruquintinib will be administered orally at a dose of 5 mg/d, 3 weeks on, 1 week off (4 weeks as a cycle) until progression, unacceptable toxicity, or withdrawal unless toxicity not relieved after dose adjustment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
（2） Age ≥18 years. （3） Histologically or cytologically confirmed diagnosis of advanced or metastatic biliary tract adenocarcinoma （4） First-line chemotherapy failed (tumor progression or intolerable adverse events).
（5） The expected survival is no less than 3 months. （6） ECOG PS≤1. （7） At least one measurable lesion according to RECIST 1.1 criteria. （8） Adequate organ function including the following:
* Total bilirubin ≤3 times upper limit of normal (ULN),
* Aspartate transaminase (AST) and alanine transaminase (ALT) ≤5×ULN,
* Alkaline phosphatase≤2.5×ULN (If the tumor invaded the liver, ≤5×ULN),
* Serum creatinine≤1.5×ULN,
* Serum amylase and lipase≤1.5×ULN,
* International standardized ratio (INR)/partial prothrombin time (PTT)≤1.5×ULN;
* Platelet count ≥ 75,000 /mm3.
* Hemoglobin (Hb) ≥ 9 g/dL.
* Absolute neutrophil count (ANC) ≥ 1500/mm3. （9） Strict contraception.
Exclusion Criteria
（3） Uncontrolled hypertension (systolic pressure ≥140 mm Hg or diastolic pressure ≥ 90 mm Hg on repeated measurement) despite optimal medical management.
（4） Active or clinically significant cardiac disease:
* Congestive heart failure \> New York Heart Association (NYHA ) class 2;
* Active coronary artery disease;
* Arrhythmias requiring treatment other than β-blocker or digoxin;
* Unstable angina (with angina symptoms at rest), new angina within 3 months before enrollment, or new myocardial infarction within 6 months before enrollment （5） Evidence or history of bleeding diathesis or coagulopathy. （6） Grade 3 bleeding events 4 weeks before enrollment. （7） Thromboembolism or arteriovenous events, such as cerebrovascular events (including transient ischemic attack), deep vein thrombosis or pulmonary embolism, occurred 6 months before enrollment.
（8） Currently taking anticoagulants. （9） Other tumors that have not been treated or exist at the same time, except carcinoma in situ of the cervix, treated basal cell carcinoma or superficial bladder tumor. If the tumor has been cured and no evidence of disease has been found for more than 3 years, the patient can be enrolled. All other tumors must be treated at least 3 years before enrollment.
（10） Patients with pheochromocytoma. （11） Patients with a history of HIV infection or active hepatitis B/C. （12） Ongoing \> level 2 infection. （13） Symptomatic brain metastasis or meningioma. （14） Unhealed wounds, ulcers or fractures. （15） Renal failure patients requiring blood or peritoneal dialysis. （16） Dehydration≥ 1 grade （17） Epileptic that need medication （18） Proteinuria≥ 3 grade (Urinary protein \> 3.5g / 24hour) （19） Active, symptomatic interstitial pneumonia, pleural or ascites that causes dyspnea (dyspnea ≥ 2 grade) （20） History of organ transplantation. (including corneal transplantation). （21） Allergic to research drugs or similar drugs, or suspected allergies. （22） Malabsorption patients. （23） Pregnant or lactating women. （24） Investigator believes that patients who are not suitable for the study. （25） Medical, psychological or social conditions can affect the recruitment of patients and evaluation for study results.
（26） Other anti-tumor therapy (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) other than investigator drugs (fruquintinib). Palliative external irradiation for non-target lesions is allowed.
（27） Previously used fruquintinib or other angiogenesis inhibitors. （28） Major surgery 4 weeks before recruitment, open biopsy or major trauma surgery. (excluding biliary stents, or percutaneous biliary drainage) （29） Treatment with anti-tumor Chinese herbal medicine. （30） History of allogeneic blood transfusion within 6 months.
18 Years
ALL
No
Sponsors
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Sichuan University
OTHER
Responsible Party
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Zhen-Yu Ding
Professor
Principal Investigators
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Qiu Li, M.D.
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
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Chinese PLA General Hospital 5th Medical Center
Beijing, Beijing Municipality, China
Hebei Tumor Hospital
Shijiazhuang, Hebei, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Jilin Cancer Hospital
Changchun, Jilin, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, China
West China Hospital, Sichuan University
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IIT-2165
Identifier Type: -
Identifier Source: org_study_id
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