Overview

Fruquintinib as Second-line Treatment for Advanced/Metastatic Biliary Tract Adenocarcinoma

Status:
Not yet recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
Summary
The prospective, multicenter, single-arm design study is to evaluate the efficacy and safety of fruquintinib for patients with advanced or metastatic biliary tract adenocarcinoma who failed first-line chemotherapy with gemcitabine, platinum/S-1, and albumin paclitaxel.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sichuan University
Criteria
Inclusion Criteria:

- (1) Patients must be able to understand and be willing to sign the written informed
consent form. A signed informed consent form must be appropriately obtained prior to
the conduct of any trial-specific procedure.

(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:

- (1) Unable to comply with the research program or procedures. (2) Undergoing other
drug clinical trials, or has participated in any drug clinical trials one month before
enrollment.

(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.