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

NCT04156958 | Unknown Phase 2

• 1 other identifier: IIT-2165
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Biliary Tract Adenocarcinoma

Keywords

biliary tract adenocarcinoma; fruquintinib; anti-angiogenesis

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Defined as the time from the date of enrollment to the first date of documented objective progression disease or of death from any cause

  Up to 5 years

Secondary Outcomes (4)

• Objective response rate (ORR)

  Up to 5 years

• Disease control rate (DCR)

  Up to 5 years

• Overall survival (OS)

  Up to 5 years

• Safety and Tolerability

  3 months after the last administration of fruquintinib

Study Arms (1)

Fruquintinib Arm

OTHER

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.

Drug: Fruquintinib

Interventions

Fruquintinib DRUG

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.

Also known as: Elunate

Fruquintinib Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• （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.

You may not qualify if:

• （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.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (7)

Chinese PLA General Hospital 5th Medical Center

Beijing, Beijing Municipality, China

Location

Hebei Tumor Hospital

Shijiazhuang, Hebei, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Jilin Cancer Hospital

Changchun, Jilin, China

Location

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Interventions

HMPL-013

Study Officials

• Qiu Li, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiu Li, M.D.

CONTACT

+86-28-85422589; fbqiu9@163.com

Pengfei Zhang, M.D.

CONTACT

+86-17828163584; fly_121988@126.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: Professor

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: December 1, 2019
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 8, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)