Biliary Tract CancerPhase 3TAB-2NCT07062263
Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients
A Phase 3 study testing Trastuzumab and Chemotherapy in people with Biliary Tract Cancer and HER2-positive Cancer, run by Tata Memorial Centre at 6 sites in India.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Biliary Tract Cancer, HER2-positive Cancer, Advanced Cancer
- What is being tested?
- Trastuzumab and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 6 sitesIndia
- Study dates
- 21 Jul 2023to 31 Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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, alkaline phosphatase ≤ 6 x upper limit normal (ULN) S. albumin ≥ 30 g/L.
- Renal function- Creatinine ≤ 1.5 ULN, Creatinine clearance >= 30 mL/min.
- 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.
- Subjects 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.
- Subjects 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 also be eligible provided the interventions have been completed 3 and 2 weeks, respectively, before enrolment in the study.
- 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.
Who cannot join
- 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 cervix.
- Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
India6 sites, 6 recruiting
- Not yet recruiting
Institute of Medical Sciences & SUM Hospital
Bhubaneswar, Odisha, 751003
Soumya S Panda, DM, 8895370579, soumyasurathpanda@soa.ac.in
- Not yet recruiting
MAX Super Speciality Hospital, SAKET
Delhi, 110017
Dr Atul Sharma, DM, 9958048055, atul1@hotmail.com
- Recruiting
Homi Bhabha Cancer Hospital and Research Centre
Mūllānpur, Punjab, 140901
Pragyat Thakur, +910160 281 0022, pragyat28rpgmc@gmail.com
Pragyat Thakur
- Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra, 400012
Vikas Ostwal, DM, 0222417000 ext. 6323, dr.vikas.ostwal@gmail.com
Anant Ramaswamy, DM, 0222417000 ext. 6323, anantr13@gmail.com
- Not yet recruiting
Homi Bhabha Cancer Hospital and Research Centre, Muzaffarpur
Muzaffarpur, Bihar, 842004
Dr Gaurav Kumar, MD, 0621-2232032 ext. 122, gaurav_crj@rediffmail.com
- Recruiting
Mahamana Pandit Madan Mohan Malviya Cancer Centre (MPMMC) and Homi Bhabha Cancer Hospital (HBCH)
Varanasi, Uttar Pradesh, 221005
Dr Bal Krishna Mishra, MD, 9415214254, bkmmishra@hotmail.com
About this study
Official title: Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients - a Randomized Non-blinded Two-arm Phase III Prospective Clinical Trial (TAB-2 Study).
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.
Eligible patients with histologically confirmed HER2-positive (IHC 3+ or IHC 2+ with FISH amplification) unresectable or metastatic biliary tract adenocarcinoma-including gallbladder cancer, intrahepatic, and perihilar cholangiocarcinoma-will be randomized in a 1:1 ratio. Participants in the intervention arm (Arm A) will receive either gemcitabine and cisplatin with or without nab-paclitaxel plus trastuzumab, while those in the control arm (Arm B) will receive chemotherapy alone (gemcitabine + cisplatin with or without nab-paclitaxel). Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or death.
The primary endpoint is 6-month progression-free survival (PFS). Secondary endpoints include overall survival (OS), response rate (RR), quality of life (QOL), and adverse event (AE) profiles. The study aims to enroll 196 patients across a single center in India over a period of 5 years, with an additional 6-month follow-up. This trial builds on earlier Phase II findings suggesting improved outcomes with trastuzumab in HER2-positive BTC and aims to provide the first randomized evidence for the benefit of HER2-targeted therapy in this setting.
Read the detailed description
Title of study- Trastuzumab plus chemotherapy vs Chemotherapy alone in first-line HER2 positive advanced biliary tract cancer patients - a randomized non-blinded two-arm Phase III prospective clinical trial (TAB - 2 study)
Indication- HER2-positive advanced/metastatic biliary tract cancers fit for first-line chemotherapy with gemcitabine-based combination
Type of Study- Two arm open-label prospective Phase III parallel design randomized superiority clinical trial
Biliary tract cancers (BTC), including gallbladder cancer and cholangiocarcinomas, are uncommon but aggressive tumors with poor prognosis in the advanced or metastatic setting. The current standard first-line treatment is gemcitabine combined with a platinum agent, which offers limited benefit. Emerging molecular profiling has identified HER2 overexpression or amplification in a subset of BTCs, particularly in gallbladder cancer, and has opened new avenues for targeted therapy.
Trastuzumab, a monoclonal antibody targeting the HER2 receptor, has shown clinical activity in HER2-positive BTCs in early-phase studies. Preliminary evidence from a single-arm Phase II study (TAB trial) suggests that combining trastuzumab with chemotherapy may significantly improve progression-free survival in treatment-naïve HER2-positive patients.
The TAB-2 study is a prospective, randomized, open-label Phase III trial designed to evaluate whether adding trastuzumab to first-line chemotherapy improves clinical outcomes in patients with HER2-positive advanced BTC. Patients will be randomized to receive chemotherapy with or without trastuzumab. Chemotherapy regimens may include gemcitabine and cisplatin, with or without nab-paclitaxel, based on physician discretion. Trastuzumab will be administered every three weeks along with chemotherapy until disease progression, unacceptable toxicity, or withdrawal of consent.
The study will be conducted at a single academic center in India, with a planned enrollment of 196 participants over 5 years. This trial aims to provide definitive randomized evidence regarding the benefit of incorporating HER2-targeted therapy into the first-line treatment of advanced BTC and to inform future clinical practice for this rare molecular subtype.
Primary endpoint- To evaluate the difference in progression-free survival (PFS) at 6 months between Trastuzumab - chemotherapy combination and chemotherapy alone.
Treatment scheme
- Arm A (Trastuzumab plus chemotherapy)-Gemcitabine plus Trastuzumab OR Gemcitabine Plus Cisplatin Plus Nab-paclitaxel on D1 and D8 Plus Trastuzumab D1 Start of next cycle on D 22
- Arm B (Chemotherapy alone)- Gemcitabine Plus Cisplatin D1 and D8 q 21 days OR Gemcitabine Plus Cisplatin Plus Nab-paclitaxel D1 and D8) Start of next cycle on D 22 Treatment in both arms will be continued till unacceptable toxicity, death, or consent withdrawal.
In both arms Immunotherapy is allowed as per the discretion of the treating physician
Sample Size calculation- Based published phase 2 single-arm TAB trial, the median PFS in HER2 positive biliary tract cancer with Trastuzumab plus chemotherapy was approximately 8 months (6-month PFS was approximately 75 - 80%), while the median PFS with chemotherapy alone ranges from 5-6 months (6-month PFS approximately 55%-65%). Assuming the Trastuzumab combination will increase the 6-month PFS to 75% in comparison to 55% with chemotherapy alone, with a power of 80% and alpha of 0.05 and margin of risk difference of 3 %, a Phase III randomized study will require a total of 196 patients (98 per arm), assuming an attrition rate of 5 % per arm with a study accrual period of 5 years. Follow up the duration of the study will be 6 months post-accrual of the last patient.
- Conditions
- Biliary Tract Cancer, HER2-positive Cancer, Advanced Cancer, Unresectable Biliary Tract Carcinoma, Metastatic Biliary Tract Carcinoma
- Being tested
- Trastuzumab, Chemotherapy
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Also called Transtuzumab with standand of chemotherapy
Inj Trastuzumab given in a dose of 8mg/kg intravenously over 90 mins as first dose and subsequent doses at a dose of 6mg/kg intravenously over 30-60 minutes in 3 weekly cycle along with standard of care chemotherapy
ChemotherapyDrug
Also called Standard of chemotherapy, Gemcitabine, cisplatin, Nab-Paclitaxel
Gemcitabine + cisplatin OR Gemcitabine-cisplatin-Nab-Paclitaxel given as a standard of care, chemotherapy as per the institutional guidlines
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Trastuzumab plus Chemotherapy | Experimental | Trastuzumab + Gemcitabine + cisplatin
* Gemcitabine 1000 mg/m2 IV over 30 mins on day 1 and day 8 q 3 weekly
* Cisplatin 25 mg/m2 IV over 60 minutes on day 1 and day 8 q 3 weekly
* Trastuzumab 8mg/kg IV over 90 mins as first dose and subsequent doses at 6mg/kg IV over 30-60 minutes q 3 weekly (=1 cycle)
OR
* Trastuzumab with Gemcitabine-cisplatin-Nab-Paclitaxel
* Gemcitabine 800 mg/m2 IV over 30 mins on day 1 and day 8 q 3 weekly
* Nab-paclitaxel 100 mg/m2 IV over 1-2 hours on day 1 and day 8 q 3 weekly
* Cisplatin 25 mg/m2 IV over 60 minutes on day 1 and day 8 q 3 weekly
* Trastuzumab 8mg/kg IV over 90 mins as first dose and subsequent doses at 6mg/kg IV over 30-60 minutes q 3 weekly (=1 cycle) Start of next cycle on D22 Immunotherapy is allowed as per the discretion of the treating physician Receives: Drug: Trastuzumab; Drug: Chemotherapy |
| Arm B: Chemotherapy alone | Active comparator | Gemcitabine + cisplatin
* Gemcitabine 1000 mg/m2 IV over 30 mins on day 1 and day 8 q 3 weekly
* Cisplatin 25 mg/m2 IV over 60 minutes on day 1 and day 8 q 3 weekly (=1 cycle)
OR
* Gemcitabine-cisplatin-Nab-Paclitaxel
* Gemcitabine 800 mg/m2 IV over 30 mins on day 1 and day 8 q 3 weekly
* Nab-paclitaxel 100 mg/m2 IV over 1-2 hours on day 1 and day 8 q 3 weekly =Cisplatin 25 mg/m2 IV over 60 minutes on day 1 and day 8 q 3 weekly (=1 cycle) Start of next cycle on D22 Immunotherapy is allowed as per the discretion of the treating physician Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
the time from the time of diagnosis of an advanced disease to the time of disease progression or loss to follow-up or death, whichever is earlier
Measured: at 6 month after randomisation
Secondary outcomes (4)
Overall survival (OS)
the time from the time of diagnosis to the time of death, lost to follow-up or last observation, whichever is earlier
Measured: at 6month, 1 year from the date of randomisation or till the time of death, lost to follow-up or last observation, whichever is earlier
Response rates
measured as per RECIST criteria in CE CT scan as compare with the baseline scans
Measured: at 6th month from the date of randomisation
Quality of life (QOL)
measured using the EORTC-QLQ-30 questionnaires All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level
Measured: at baseline and at completion of 4 cycles of chemotherapy (each cycle is 22 days)
Safety profile
side effects and adverse event profile with the combination will be reported as NCI-CTCAE v5.0
Measured: "At the end of each Cycle (each cycle is 22 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start21 Jul 2023
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Tata Memorial CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III open-label parallel design randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Vikas Ostwal, Tata Memorial Centre
- Investigators
- Vikas Ostwal, DM, Principal investigator, Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India 400012
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07062263
- Sponsor's protocol ID
- 4172
- Acronym
- TAB-2
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trastuzumab Plus Chemotherapy vs Chemotherapy Alone in First-line HER2 Positive Advanced Biliary Tract Cancer Patients - a Randomized Non-blinded Two-arm Phase III Prospective Clinical Trial (TAB-2 Study).
- ClinicalTrials.gov ID
- NCT07062263
- Acronym / sponsor ID
- TAB-2 / 4172
- Conditions
- Biliary Tract Cancer, HER2-positive Cancer, Advanced Cancer, Unresectable Biliary Tract Carcinoma, Metastatic Biliary Tract Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Tata Memorial CentreUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Eligible patients with histologically confirmed HER2-positive (IHC 3+ or IHC 2+ with FISH amplification) unresectable or metastatic biliary tract adenocarcinoma-including gallbladder cancer, intrahepatic, and perihilar cholangiocarcinoma-will be randomized in a 1:1 ratio. Participants in the intervention arm (Arm A) will receive either gemcitabine and cisplatin with or without nab-paclitaxel plus trastuzumab, while those in the control arm (Arm B) will receive chemotherapy alone (gemcitabine + cisplatin with or without nab-paclitaxel). Treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, or death.
The primary endpoint is 6-month progression-free survival (PFS). Secondary endpoints include overall survival (OS), response rate (RR), quality of life (QOL), and adverse event (AE) profiles. The study aims to enroll 196 patients across a single center in India over a period of 5 years, with an additional 6-month follow-up. This trial builds on earlier Phase II findings suggesting improved outcomes with trastuzumab in HER2-positive BTC and aims to provide the first randomized evidence for the benefit of HER2-targeted therapy in this setting.
Detailed description
Title of study- Trastuzumab plus chemotherapy vs Chemotherapy alone in first-line HER2 positive advanced biliary tract cancer patients - a randomized non-blinded two-arm Phase III prospective clinical trial (TAB - 2 study)
Indication- HER2-positive advanced/metastatic biliary tract cancers fit for first-line chemotherapy with gemcitabine-based combination
Type of Study- Two arm open-label prospective Phase III parallel design randomized superiority clinical trial
Biliary tract cancers (BTC), including gallbladder cancer and cholangiocarcinomas, are uncommon but aggressive tumors with poor prognosis in the advanced or metastatic setting. The current standard first-line treatment is gemcitabine combined with a platinum agent, which offers limited benefit. Emerging molecular profiling has identified HER2 overexpression or amplification in a subset of BTCs, particularly in gallbladder cancer, and has opened new avenues for targeted therapy.
Trastuzumab, a monoclonal antibody targeting the HER2 receptor, has shown clinical activity in HER2-positive BTCs in early-phase studies. Preliminary evidence from a single-arm Phase II study (TAB trial) suggests that combining trastuzumab with chemotherapy may significantly improve progression-free survival in treatment-naïve HER2-positive patients.
The TAB-2 study is a prospective, randomized, open-label Phase III trial designed to evaluate whether adding trastuzumab to first-line chemotherapy improves clinical outcomes in patients with HER2-positive advanced BTC. Patients will be randomized to receive chemotherapy with or without trastuzumab. Chemotherapy regimens may include gemcitabine and cisplatin, with or without nab-paclitaxel, based on physician discretion. Trastuzumab will be administered every three weeks along with chemotherapy until disease progression, unacceptable toxicity, or withdrawal of consent.
The study will be conducted at a single academic center in India, with a planned enrollment of 196 participants over 5 years. This trial aims to provide definitive randomized evidence regarding the benefit of incorporating HER2-targeted therapy into the first-line treatment of advanced BTC and to inform future clinical practice for this rare molecular subtype.
Primary endpoint- To evaluate the difference in progression-free survival (PFS) at 6 months between Trastuzumab - chemotherapy combination and chemotherapy alone.
Treatment scheme
- Arm A (Trastuzumab plus chemotherapy)-Gemcitabine plus Trastuzumab OR Gemcitabine Plus Cisplatin Plus Nab-paclitaxel on D1 and D8 Plus Trastuzumab D1 Start of next cycle on D 22
- Arm B (Chemotherapy alone)- Gemcitabine Plus Cisplatin D1 and D8 q 21 days OR Gemcitabine Plus Cisplatin Plus Nab-paclitaxel D1 and D8) Start of next cycle on D 22 Treatment in both arms will be continued till unacceptable toxicity, death, or consent withdrawal.
In both arms Immunotherapy is allowed as per the discretion of the treating physician
Sample Size calculation- Based published phase 2 single-arm TAB trial, the median PFS in HER2 positive biliary tract cancer with Trastuzumab plus chemotherapy was approximately 8 months (6-month PFS was approximately 75 - 80%), while the median PFS with chemotherapy alone ranges from 5-6 months (6-month PFS approximately 55%-65%). Assuming the Trastuzumab combination will increase the 6-month PFS to 75% in comparison to 55% with chemotherapy alone, with a power of 80% and alpha of 0.05 and margin of risk difference of 3 %, a Phase III randomized study will require a total of 196 patients (98 per arm), assuming an attrition rate of 5 % per arm with a study accrual period of 5 years. Follow up the duration of the study will be 6 months post-accrual of the last patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase III open-label parallel design randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Arm A: Trastuzumab plus Chemotherapy | Experimental | Drug: Trastuzumab, Drug: ChemotherapyTrastuzumab + Gemcitabine + cisplatin * Gemcitabine 1000 mg/m2 IV over 30 mins on day 1 and day 8 q 3 weekly * Cisplatin 25 mg/m2 IV over 60 minutes on day 1 and day 8 q 3 weekly * Trastuzumab 8mg/kg IV over 90 mins as first dose and subsequent doses at 6mg/kg IV over 30-60 minutes q 3 weekly (=1 cycle) OR * Trastuzumab with Gemcitabine-cisplatin-Nab-Paclitaxel * Gemcitabine 800 mg/m2 IV over 30 mins on day 1 and day 8 q 3 weekly * Nab-paclitaxel 100 mg/m2 IV over 1-2 hours on day 1 and day 8 q 3 weekly * Cisplatin 25 mg/m2 IV over 60 minutes on day 1 and day 8 q 3 weekly * Trastuzumab 8mg/kg IV over 90 mins as first dose and subsequent doses at 6mg/kg IV over 30-60 minutes q 3 weekly (=1 cycle) Start of next cycle on D22 Immunotherapy is allowed as per the discretion of the treating physician |
| Arm B: Chemotherapy alone | Active comparator | Drug: ChemotherapyGemcitabine + cisplatin * Gemcitabine 1000 mg/m2 IV over 30 mins on day 1 and day 8 q 3 weekly * Cisplatin 25 mg/m2 IV over 60 minutes on day 1 and day 8 q 3 weekly (=1 cycle) OR * Gemcitabine-cisplatin-Nab-Paclitaxel * Gemcitabine 800 mg/m2 IV over 30 mins on day 1 and day 8 q 3 weekly * Nab-paclitaxel 100 mg/m2 IV over 1-2 hours on day 1 and day 8 q 3 weekly =Cisplatin 25 mg/m2 IV over 60 minutes on day 1 and day 8 q 3 weekly (=1 cycle) Start of next cycle on D22 Immunotherapy is allowed as per the discretion of the treating physician |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (11 listed)
- 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 cervix.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrastuzumabAlso: Transtuzumab with standand of chemotherapyInj Trastuzumab given in a dose of 8mg/kg intravenously over 90 mins as first dose and subsequent doses at a dose of 6mg/kg intravenously over 30-60 minutes in 3 weekly cycle along with standard of care chemotherapy | Drug | Arm A: Trastuzumab plus Chemotherapy |
| ChemotherapyAlso: Standard of chemotherapy, Gemcitabine, cisplatin, Nab-PaclitaxelGemcitabine + cisplatin OR Gemcitabine-cisplatin-Nab-Paclitaxel given as a standard of care, chemotherapy as per the institutional guidlines | Drug | Arm A: Trastuzumab plus Chemotherapy, Arm B: Chemotherapy alone |
Primary outcome
Progression-free survival (PFS)
Time frame: at 6 month after randomisation
the time from the time of diagnosis of an advanced disease to the time of disease progression or loss to follow-up or death, whichever is earlier
4 secondary outcomes
Overall survival (OS)
Time frame: at 6month, 1 year from the date of randomisation or till the time of death, lost to follow-up or last observation, whichever is earlier
Response rates
Time frame: at 6th month from the date of randomisation
Quality of life (QOL)
Time frame: at baseline and at completion of 4 cycles of chemotherapy (each cycle is 22 days)
Safety profile
Time frame: "At the end of each Cycle (each cycle is 22 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vikas Ostwal, DM principal investigator
Tata Memorial Hospital, Parel, Mumbai, Maharashtra, India 400012
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trastuzumab and Chemotherapy in people with Biliary Tract Cancer and HER2-positive Cancer, run by Tata Memorial Centre at 6 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vikas S Ostwal, DM (0222417000 ext. 6323, dr.vikas.ostwal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: at 6 month after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.