Trastuzumab in advanced biliary tract cancers

Phase 2

Conditions: Health Condition 1: C249- Malignant neoplasm of biliary tract, unspecified

Registration Number: CTRI/2019/11/021955

Lead Sponsor: Tata Memorial Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

histologically confirmed adenocarcinoma of the biliary tract, with the following specifications

Biliary tract cancers including gallbladder cancer, intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma HER2-positive by IHC or FISH (detailed later)

ECOG performance status 0 - 1

Patient who can give informed consent for the study.

Patient does not have any contraindications to receive chemotherapy, or trastuzumab

Adequate hematological, hepatic and renal function parameters

Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography, ejection fraction ejection fraction equal or more than 50% or above lower limit of normal.

ECG with no clinical relevant abnormalities

Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.

No major surgery within last 4 weeks

written patient consent form

Exclusion Criteria

distal cholangiocarcinoma which would be considered as ampullary carcinomas

Known hypersensitivity or contraindications against gemcitabine, cisplatin or trastuzumab

clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA III-IV,

Clinically significant valvular defect

Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix

Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy

Other severe internal disease or acute infection

Baseline neuropathy more NCI Grade I

Chronic inflammatory bowel disease

Unhealed surgical wounds

On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study

Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment

Received any prior chemotherapy / radiotherapy or cancer directed therapy

Any active ILD or history of lung illness requiring bronchodilator drugs.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of the study is to estimate the median PFS % at 6 months with gemcitabine-cisplatin-trastuzumabTimepoint: 60 months

Secondary Outcome Measures

Name	Time	Method
estimate the median -OS % at 6 months with gemcitabine-cisplatin-trastuzumab <br/ ><br>-comparing the tolerance of gemcitabine-cisplatin - trastuzumab <br/ ><br>-estimating the quality of life while on treatmentTimepoint: 60 months