Clinical trial · Interventional
Clinical Trial of Adjuvant Chemotherapy Followed by Concurrent Chemoradiotherapy Compared With Adjuvant Chemotherapy Alone in Patients With Gallbladder Carcinoma and Extrahepatic Cholangiocarcinoma
NCT02798510CI-TRIAL-00022685unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The present study is designed to determine whether adjuvant concurrent chemoradiotherapy improves overall survivals.
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 |
|---|---|---|---|
| Malignant Neoplasm Other Gallbladder/Extrahepatic Bile Duct | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| Concurrent Chemoradiotherapy | Radiation | — | UNRESOLVED |
| gemcitabine | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- Patients in arm 1 will receive adjuvant chemotherapy followed by concurrent chemoradiotherapy. Patients will receive four cycles of gemcitabine (1,000mg/m2 intravenously on days 1 and 8) and capecitabine (1,500mg/m2 per day on days 1 to 14) every 21 days followed by concurrent capecitabine (1,330mg/m2 per day) and radiotherapy (50.4Gy/28fx to regional lymphatics with or without tumor bed)
- interventionNames
- Radiation: Concurrent Chemoradiotherapy
- Drug: capecitabine
- Drug: gemcitabine
- type
- ACTIVE_COMPARATOR
- label
- Arm 2
- description
- Patients in arm 2 will receive six cycles chemotherapy of gemcitabine (1,000mg/m2 intravenously on days 1 and 8) and capecitabine (1,500mg/m2 per day on days 1 to 14) every 21 days
- interventionNames
- Drug: capecitabine
- Drug: gemcitabine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * The patients with pathologic diagnosis of gallbladder carcinoma (GBCA) or extrahepatic cholangiocarcinoma (EHCC) after radical resection. * The patients with pathologic stage T2-4 or N1 in R0 resection or positive resection margins (R1). * Aged 18 to 70 years old, male or female, body condition score generally ECOG 0~2, expected survival ≥ 6 months. * Subjects were no major organ dysfunction, blood, liver, kidney and heart function was normal, the specific requirements of laboratory indicators: * Blood: Absolute neutrophil count \> 1.5 × 109 / L, Platelet count \> 100 × 109 / L, Hb \> 8.0g/dl. * Liver function: serum bilirubin less than 1.5 times the upper limit of normal; ALT and AST less than 2.5 times the upper limit of normal. * Renal function: creatinine less than 1.5 times the upper limit of normal. * Patients who can understand the circumstances of this study and signed informed consent. Exclusion Criteria: * Pregnancy, breast-feeding patients; * Patients received prior anticancer therapy for the current malignancy or upper abdominal radiotherapy or chemotherapy at any time. * Patients with malignant ascites. * Patients with purulent and chronic infected wounds which delayed healing. * Patients with liver, kidney and heart failure and coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, stroke and other serious cardiovascular and cerebrovascular disease; * Patients has a history of mental illness and difficult to control; * Patients who was considered inappropriate to participate in the trials by the researchers.
References
Publications (1)
- DERIVEDLuvira V, Satitkarnmanee E, Pugkhem A, Kietpeerakool C, Lumbiganon P, Pattanittum P. Postoperative adjuvant chemotherapy for resectable cholangiocarcinoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD012814. doi: 10.1002/14651858.CD012814.pub2. PMID 34515993