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Compares treatment options for Biliary Tract Cancer
Official title Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients
ClinicalTrials.gov ID: NCT07062263
What this study is testing
What is Trastuzumab?
Trastuzumab is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for biliary tract cancer.
Also referred to as Transtuzumab with standand of chemotherapy.
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
- This is a randomized, open-label, two-arm, Phase III clinical trial evaluating the efficacy and safety of trastuzumab plus chemotherapy versus chemotherapy alone as first-line treatment in patients with HER2-positive advanced or metastatic biliary tract cancers (BTC). HER2-positive BTCs represent a molecular subset of these rare cancers, associated with poor prognosis and limited treatment options.
- Phase 3: a large, late-stage study
- Time commitment: about 5 years
- 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 to 99
You may be able to join if
- Histologically confirmed adenocarcinoma of the biliary tract, with the following specifications -
- Biliary tract cancers include gallbladder cancer, intrahepatic cholangiocarcinoma, and perihilar cholangiocarcinoma.
- HER2-positive by IHC or FISH
- Age \>=18 years.
- ECOG performance status 0 - 2.
You likely can't join if
- Distal cholangiocarcinoma
- Known hypersensitivity or contraindications against gemcitabine, cisplatin, Nab- paclitaxel, 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...
- Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
See the full eligibility criteria
- Histologically confirmed adenocarcinoma of the biliary tract, with the following specifications -
- Biliary tract cancers include gallbladder cancer, intrahepatic cholangiocarcinoma, and perihilar cholangiocarcinoma.
- HER2-positive by IHC or FISH
- Age \>=18 years.
- ECOG performance status 0 - 2.
- Unresectable or metastatic cancer.
- Patient does not have any contraindications to receive chemotherapy or trastuzumab.
- Adequate hematological, hepatic, and renal function parameters- Hematological- Hb\> 80 g/L, ANC ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L. Liver functions- bilirubin ≤ 2 x upper limit normal (ULN), AST/ALT ≤ 5 x ULN...
- Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography, ejection fraction (EF) \>=50% or above the lower limit of normal. ECG with no clinically 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.
- people must provide written informed consent prior to the performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up assessments and procedures.
- people who have received adjuvant chemotherapy will be considered eligible provided that therapy is completed more than 12 months before study enrollment. Patients who have received radiation therapy and surgery will...
- Negative serum pregnancy test (if applicable) and willing for adequate contraception.
- At least one measurable disease according to RECIST criteria.
- Life expectancy of at least 12 weeks.
- Distal cholangiocarcinoma
- Known hypersensitivity or contraindications against gemcitabine, cisplatin, Nab- paclitaxel, 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...
- Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
- Baseline neuropathy \> NCI Grade I.
- Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.
- Received prior chemotherapy within 1 year.
- Any active ILD/ history of lung illness requiring bronchodilator drugs.
- Patients with prior chemotherapy for metastatic disease will be ineligible for enrollment in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Muzaffarpur, Bihar, India
- Mumbai, Maharashtra, India
- Bhubaneswar, Odisha, India
- Mūllānpur, Punjab, India
- Varanasi, Uttar Pradesh, India
- Delhi, India
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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Muzaffarpur, Bihar, India; Mumbai, Maharashtra, India; Bhubaneswar, Odisha, India; Mūllānpur, Punjab, India; Varanasi, Uttar Pradesh, India; Delhi, India. 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.