18 and older, any sex, with Stage III Intrahepatic Cholangiocarcinoma AJCC v7 or Stage IIIA Gallbladder Cancer AJCC v7. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median Progression Free Survival (PFS)Primary· up to 3 years
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Group
Value
95% CI
High Dosage
11.4
6.0 – 15.6
Low Dosage
14.9
3.8 – NA
Median Overall Survival (OS)Secondary· up to 3 years
The Kaplan-Meier method was used to estimate OS, with surviving patients censored at the time of surgery or at last known follow-up.
Group
Value
95% CI
High Dose
19.5
10 – NA
Low Dose
15.7
8.7 – NA
Number of Participants With Treatment Response RateSecondary· Up to 2 years
Per Response Evaluation Criteria In Solid Tumors Criteria(RECIST v1.1.14) 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.
Disease Control Rate(DCR)
Group
Value
95% CI
High Dose
25
Low Dose
18
Complete Response(CR)
Group
Value
95% CI
High Dose
0
Low Dose
0
Partial Response (PR)
Group
Value
95% CI
High Dose
14
Low Dose
9
Stable Disease(SD)
Group
Value
95% CI
High Dose
11
Low Dose
9
Progressive Disease(PD)
Group
Value
95% CI
High Dose
3
Low Dose
5
Unknown
Group
Value
95% CI
High Dose
4
Low Dose
5
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 3 years.
Reporting threshold: 1%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This phase II trial studies how well gemcitabine hydrochloride, cisplatin, and nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation) work in treating patients with biliary cancers (which includes the gallbladder and bile ducts inside and outside the liver) that have spread to other places in the body and usually cannot be cured or controlled with treatment. Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and paclitaxel albumin-stabilized nanoparticle formulation, 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 more than one drug (combination chemotherapy) may kill more tumor cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa
· Phase 2
· recruiting
NCT07195734 — Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer
· Phase 2
· recruiting
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP)
· Phase 1
· not yet recruiting
NCT05521997 — Glutaminase Inhibition and Chemoradiation in Advanced Cervical Cancer
· Phase 2
· not yet recruiting
NCT06724042 — Study of ISM5939 in Patients With Advanced and/or Metastatic Solid Tumors
· Phase 1
· not yet recruiting
Other recruiting trials for Stage III Intrahepatic Cholangiocarcinoma AJCC v7
Currently open trials in the same condition.
NCT03257761 — Guadecitabine and Durvalumab in Treating Patients With Advanced Liver, Pancreatic, Bile Duct, or Gallbladder Cancer
· Phase 1
· active not recruiting
Other M.D. Anderson Cancer Center trials
Trials by the same sponsor.
NCT07053020 — A Phase 1b/2 Open-label, Dose-ranging Safety and Efficacy Study of Oral Cladribine in Patients With Acute Myeloid Leukem
· Phase 1, PHASE2
· not yet recruiting
NCT07052994 — A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and
· Phase 1
· not yet recruiting
NCT07137481 — Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Che
· Phase 2
· not yet recruiting
NCT07162480 — Phase II Trial of Puxitatug Samrotecan (AZD8205) in Advanced, Recurrent or Metastatic (R/M) Aggressive Adenoid Cystic Ca
· Phase 2
· not yet recruiting
NCT07076498 — Engineered HSV-1 M032 for the Treatment of Children and Adults With Newly Diagnosed Diffuse Midline Glioma After Standar
· Phase 1
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by M.D. Anderson Cancer Center
Last refreshed: 2 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02392637.