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Gemcitabine, Cisplatin, and Nab-Paclitaxel Before Surgery in Patients With High-Risk Liver Bile Duct Cancer
Phase 2 trial testing Cisplatin in Resectable Cholangiocarcinoma in 30 participants. Completed in 16 September 2023.
| Lead sponsor | Emory University |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 26 September 2018 |
| Primary completion | 16 September 2023 |
| Estimated completion | 16 September 2023 |
| Sites | 7 locations across United States |
Emory University
19 and older, any sex, with Resectable Cholangiocarcinoma or Stage IB Intrahepatic Cholangiocarcinoma AJCC v8. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Completion of all therapy rate will be recorded.
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin, Nab-paclitaxel | 22 |
Will be monitored using method of Thall, Simon and Estey, and will be tabulated by the maximum reported Common Terminology Criteria for Adverse Events (CTCAE) grade.
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin, Nab-paclitaxel | 26 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin, Nab-paclitaxel | 13 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin, Nab-paclitaxel | 2 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin, Nab-paclitaxel | 1 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin, Nab-paclitaxel | 11 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin, Nab-paclitaxel | 11 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin, Nab-paclitaxel | 15 |
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin, Nab-paclitaxel | 4 |
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin, Nab-paclitaxel | 3 | |
| Gemcitabine, Cisplatin, Nab-paclitaxel | 7 | |
| Gemcitabine, Cisplatin, Nab-paclitaxel | 20 |
RFS is defined as the time between the date of surgery and the date of disease recurrence or death, whichever occurred first. If a patient did not have an event (i.e. disease recurrence or death) by the time of final analysis, patient will be censored at the last disease evaluation time.
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin, Nab-paclitaxel | 23.7 | 17.1 – 37.1 |
OS is defined as the time from date of neoadjuvant treatment start to the date of death from any cause or to the date of last follow-up if patients are alive. If a patient is alive by the time of final analysis, the patient will be censored at the last follow-up date.
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine, Cisplatin, Nab-paclitaxel | 30 |
Time frame: 3 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Gemcitabine, Cisplatin, Na… |
|---|---|---|
| Neutrophil count decreased | Investigations | — |
| Diarrhea | Gastrointestinal disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Colitis | Gastrointestinal disorders | — |
| Dehydration | General disorders | — |
| Hypophosphatemia | Investigations | — |
| Leukocytosis | Blood and lymphatic system disorders | — |
| Reaction | System | Gemcitabine, Cisplatin, Na… |
|---|---|---|
| Fatigue | General disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Hyperglycemia | Endocrine disorders | — |
| Neutrophil count decreased | Blood and lymphatic system disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Alkaline phosphatase increased | Investigations | — |
| Constipation | Gastrointestinal disorders | — |
| Peripheral sensory neuropathy | Nervous system disorders | — |
| Platelet count decreased | Blood and lymphatic system disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| White blood cell decreased | Blood and lymphatic system disorders | — |
| Blood and lymphatic system disorders - Other, specify | Blood and lymphatic system disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| General disorders and administration site conditions - Other, specify | General disorders | — |
| Hyponatremia | Blood and lymphatic system disorders | — |
| Anxiety | Psychiatric disorders | — |
| Aspartate aminotransferase increased | Investigations | — |
| Dizziness | General disorders | — |
| Dyspnea | Gastrointestinal disorders | — |
| Hypertension | Cardiac disorders | — |
| Insomnia | Psychiatric disorders | — |
| Pain | General disorders | — |
| Blurred vision | Eye disorders | — |
| Edema limbs | Blood and lymphatic system disorders | — |
| Hiccups | Respiratory, thoracic and mediastinal disorders | — |
| Hypokalemia | Investigations | — |
| Hypomagnesemia | Blood and lymphatic system disorders | — |
| Mucositis oral | Infections and infestations | — |
| Tinnitus | Ear and labyrinth disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Bloating | Gastrointestinal disorders | — |
| Creatinine increased | Investigations | — |
| Epistaxis | Ear and labyrinth disorders | — |
| Febrile neutropenia | Infections and infestations | — |
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — |
Most-reported serious reactions: Neutrophil count decreased, Diarrhea, Anemia, Alanine aminotransferase increased, White blood cell decreased, Febrile neutropenia, Colitis, Dehydration.
Data from ClinicalTrials.gov NCT03579771 adverse events section.
This phase II trial studies how well gemcitabine, cisplatin, and nab-paclitaxel work before surgery in treating participants with high-risk bile duct cancer in the liver (intrahepatic cholangiocarcinoma). Drugs used in chemotherapy, such as nab-paclitaxel, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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