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.

Phase 3

Not yet recruiting

• Conditions: Malignant neoplasm of biliary tract, unspecified,

• Registration Number: CTRI/2023/07/055523
• Lead Sponsor: Tata Memorial Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-08
• Last Update Posted: 2025-11-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

• 1.Histologically confirmed adenocarcinoma of the biliary tract, with the following specifications 2.HER2 positive (by IHC or FISH) unresectable or metastatic Biliary tract cancers.
• 3.Age more than or equal to 18 years, ECOG performance status 0 to 2.
• 4.Patient does not have any contraindications to receive chemotherapy or trastuzumab.
• 5.Adequate hematological, hepatic, and renal function parameters 6.Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography, ejection fraction (EF) more than or equal to 50% or above the lower limit of normal.
• ECG with no clinically relevant abnormalities.
• 7.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.
• 8.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.
• 9.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 weeks, before enrolment in the study.
• 10.Negative serum pregnancy test (if applicable) and willing for adequate contraception.
• 11.At least one measurable disease according to RECIST criteria.
• 12.A life expectancy of at least 12 weeks.

Exclusion Criteria

• 1.Distal cholangiocarcinoma 2.Known hypersensitivity or contraindications against gemcitabine, cisplatin, Nab-paclitaxel, or trastuzumab.
• 3.Clinically significant active coronary heart disease, cardiomyopathy, or congestive heart failure, NYHA III to IV.
• 4.Clinically significant valvular defect.
• 5.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.
• 6.Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
• 7.Baseline neuropathy greater than NCI Grade I.
• 8.Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment.
• 9.Received prior chemotherapy within 1 year.
• 10.Any active ILD or history of lung illness requiring bronchodilator drugs.
• 11.Patients with prior chemotherapy for metastatic disease will be ineligible for enrollment in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the difference in progression free survival at 6 months between Trastuzumab chemotherapy combination & chemotherapy alone	To evaluate the difference in progression free survival at 6 months between Trastuzumab chemotherapy combination & chemotherapy alone

Secondary Outcome Measures

Name	Time	Method
To evaluate the difference in Overall Survival between the Trastuzumab chemotherapy combination & chemotherapy alone.	To evaluate the difference in overall response rates between Trastuzumab chemotherapy combination and chemotherapy alone.

Trial Locations

Locations (3)

Homi Bhabha Cancer Hospital and Research Centre (Tata Memorial Center); 🇮🇳 Chandigarh, CHANDIGARH, India

Mahamana Pandit Madan Mohan Malviya Cancer Centre (MPMMC) and Homi Bhabha Cancer Hospital (HBCH); 🇮🇳 Varanasi, UTTAR PRADESH, India

Tata Memorial Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Homi Bhabha Cancer Hospital and Research Centre (Tata Memorial Center)

🇮🇳Chandigarh, CHANDIGARH, India

Dr Alok Goel

Principal investigator

9899701286

alokdrgoel@gmail.com