Unresectable Gallbladder Cancer Clinical Trial
Official title:
A Single-arm, Multicenter, Phase II Clinical Study of the Efficacy and Safety of Carrilizumab Combinated With Gemcitabine and Oxaliplatin (GEMOX) as a Preoperative Translational Therapy for Unresectable Gallbladder Cancer
This is an open-label,multicenter ,non-randomized,single arm exploratory study. The objective of this study is to evaluate the efficacy and safety of PD-1 antibody plus GEMOX as preoperative translational therapy for unresectable gallbladder cancer.
The aim of this study was to evaluate the efficacy and safety of carrilizumab in combination with gemcitabine and oxaliplatin (GEMOX) as a preoperative conversion therapy for unresectable gallbladder cancer. Patients with unresectable gallbladder cancer were enrolled to receive gemcitabine 1000 mg/m2 D1, D8 + oxaliplatin 100 mg/m2, D1 + carrilizumab 200 mg, D1, in 21-day cycles for 6-8 cycles, with changes in serum tumor parameters assessed at each course and abdominal CTA performed every two courses.The above treatment was terminated if the CT evaluation revealed disease progression, and the investigator could adjust the treatment regimen according to the guideline. The primary outcome measure of this study is the tumor radical resection rate; secondary outcome measure are objective response rate, disease control rate, progression-free survival, and overall survival. The safety indicators are the incidence and severity of adverse events (AE) and serious adverse events (SAE) according to NCI-CTCAEv5.0 criteria. Thirty-seven cases are expected to be enrolled in this study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00949949 -
Everolimus, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable Solid Tumors Refractory to Standard Therapy
|
Phase 1 | |
| Completed |
NCT01229111 -
Cediranib Maleate and Combination Chemotherapy in Treating Patients With Advanced Biliary Cancers
|
Phase 2 | |
| Completed |
NCT00107536 -
Lapatinib Ditosylate in Treating Patients With Unresectable Liver or Biliary Tract Cancer
|
Phase 2 | |
| Completed |
NCT00238212 -
S0514 Sorafenib in Treating Patients With Unresectable or Metastatic Gallbladder Cancer or Cholangiocarcinoma
|
Phase 2 | |
| Completed |
NCT00101036 -
Lapatinib in Treating Patients With Locally Advanced or Metastatic Biliary Tract or Liver Cancer That Cannot Be Removed By Surgery
|
Phase 2 | |
| Completed |
NCT00028496 -
Vaccine Therapy With or Without Sargramostim in Treating Patients With Advanced or Metastatic Cancer
|
Phase 1 | |
| Terminated |
NCT00478140 -
Trastuzumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer or Bile Duct Cancer That Cannot Be Removed by Surgery
|
Phase 2 | |
| Completed |
NCT00356889 -
Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic or Unresectable Biliary Tumors
|
Phase 2 | |
| Terminated |
NCT00087191 -
EF5 and Motexafin Lutetium in Detecting Tumor Cells in Patients With Abdominal or Non-Small Cell Lung Cancer
|
N/A | |
| Completed |
NCT00033462 -
Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer
|
Phase 2 | |
| Terminated |
NCT01282333 -
Veliparib, Cisplatin, and Gemcitabine Hydrochloride in Treating Patients With Advanced Biliary, Pancreatic, Urothelial, or Non-Small Cell Lung Cancer
|
Phase 1 | |
| Completed |
NCT00397384 -
Erlotinib Hydrochloride and Cetuximab in Treating Patients With Advanced Gastrointestinal Cancer, Head and Neck Cancer, Non-Small Cell Lung Cancer, or Colorectal Cancer
|
Phase 1 | |
| Completed |
NCT00085410 -
Bortezomib in Treating Patients With Unresectable Locally Advanced or Metastatic Adenocarcinoma of the Bile Duct or Gallbladder
|
Phase 2 | |
| Completed |
NCT00031681 -
7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer (Currently Accruing Only Triple-negative Breast Cancer Patients Since 6/8/2007)
|
Phase 1 | |
| Terminated |
NCT00023946 -
BMS-247550 in Treating Patients With Liver or Gallbladder Cancer
|
Phase 2 | |
| Completed |
NCT00004074 -
Interleukin-12 and Trastuzumab in Treating Patients With Cancer That Has High Levels of HER2/Neu
|
Phase 1 | |
| Withdrawn |
NCT00253617 -
Stent Placement With or Without Photodynamic Therapy Using Porfimer Sodium as Palliative Treatment in Treating Patients With Stage III or Stage IV Cholangiocarcinoma That Cannot Be Removed By Surgery
|
Phase 3 |