New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma

What Was Tested

This registered phase 3 trial tested Somatostatin.

Determine quality of life of patients treated with this regimen.

Determine the toxicity of new chemotherapy regimen.

It had two arms (groups): epirubicin,cisplatin,LV（Leucovorin）、5-FU (5-Fluorouracil) (active comparator) and Somatotatin (experimental).

Conventional regimen.

Conventional chemotherapy regimen plus somatostatin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 216 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients with unresectable locally advanced disease or unresectable local recurrence, including:. Patients with unresectable local recurrence lesions. Age between 18-75, no gender-based constraints. Estimated life expectancy ≥12 weeks. KPS（Karnofsky performance status ）≥60.

The full record lists 13 inclusion and 6 exclusion criteria; among the exclusions: patients with extensive metastasis and generally poor condition who can not tolerate chemotherapy; patients who are pregnant or breastfeeding; patients who had a history of previous carcinoma in the last 5 years.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Somatostatin and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Somatostatin study: the participants and staff both knew the treatment.

It started in 2009-10 with completion listed for 2013-12.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: (Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response) (time frame: 6 month after first treatment).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Somatostatin in 216 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Somatostatin compound page, all human trials.