Clinical trial · Interventional
New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
A Phase III Study of New Chemotherapy Regimen in the Treatment of Advanced Gallbladder Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objective Primary: Determine the objective response rate in patients with advanced gallbladder treated with new Chemotherapy regimen Secondary: Determine time to progression-free survival and overall survival of patients treated with this regimen. Determine quality of life of patients treated with this regimen. Determine the toxicity of new chemotherapy regimen
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gallbladder Neoplasms | Gallbladder Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| epirubicin, cisplatin, LV(Leucovorin)、 5-FU(5-Fluorouracil) | Drug | — | UNRESOLVED |
| Somatostatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- epirubicin,cisplatin,LV(Leucovorin)、5-FU (5-Fluorouracil)
- description
- conventional regimen
- interventionNames
- Drug: epirubicin, cisplatin, LV(Leucovorin)、 5-FU(5-Fluorouracil)
- type
- EXPERIMENTAL
- label
- Somatotatin
- description
- Conventional chemotherapy regimen plus somatostatin
- interventionNames
- Drug: Somatostatin
- Drug: epirubicin, cisplatin, LV(Leucovorin)、 5-FU(5-Fluorouracil)
Primary outcomes (1)
- measure
- (Response Evaluation Criteria in Solid Tumors, RECIST,2009 ), CR(complete response) and PR(partial response)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with unresectable locally advanced disease or unresectable local recurrence, including: * Patients with unresectable advanced gallbladder cancer (≥ Nevin staging IV or TNM( tumor node metastasis) classification) * Patients with complication who have no indication for surgery * Patients with unresectable local recurrence lesions 2. Age between 18-75, no gender-based constraints 3. Estimated life expectancy ≥12 weeks 4. KPS(Karnofsky performance status )≥60 5. Each patient gave written informed consent 6. \< 2 previous chemotherapy regimes 7. No chemotherapy done in the last 4 weeks 8. Laboratory test criteria:Haemoglobin ≥ 10g/dl, white blood cell count \> 3,000/mm3 ;Platelet \>100,000/mm3 Total bilirubin \<5.0mg/dl ALT(alanine transaminase)、 AST(aspartate aminotransferase)≤ 2.5 times upper limit of normal BUN(blood urea nitrogen)≤ 2 times upper limit of normal; serum creatinine \<1.5mg/dl: creatinine clearance rate \< 60 ml/min 9. Patients are required to have histologically confirmed diagnosis via puncture based at least on computed tomography (CT) or ultrasound 10. Jaundice should be reduced to standard level before chemotherapy (Total bilirubin \<5.0 mg/dl) Exclusion Criteria: 1. Patients with extensive metastasis and generally poor condition who can not tolerate chemotherapy 2. Patients who are pregnant or breastfeeding. 3. Patients with other clinically significant laboratory abnormalities, uncontrolled infection, concurrent severe medical problems unrelated to malignancy 4. Patients who had a history of previous carcinoma in the last 5 years. 5. Patients who are allergic to somatostatin or fluorouracil 6. Patients who refuse chemotherapy, or to sign the informed consent and chemotherapy consent.
References
Publications (0)
Data not yet available