Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06320301
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-21
Brief Title:
Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers BTC
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Adebrelimab and a TKI in Combination With GEMOX in First-line Treatment of Advanced Biliary Tract Cancers BTC a Single-arm Phase II Clinical Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients with advanced biliary tract malignant tumors who had not received systematic treatment before and could not be cured were selected as the subjects of the study The primary endpoint of the study was investigator-assessed 6-month progression-free survival 6-month PFS based on the RECIST v11 criteria and 43 subjects were planned to be enrolled Patients eligible for enrollment will receive Adebrelimab and a tyrosine kinase inhibitor TKI in combination with gemcitabine and oxaliplatin GEMOX
Detailed Description:
This is an open-label single-arm clinical study to observe and evaluate the efficacy and safety of Adebrelimab PD-L1 and tyrosine kinase inhibitor TKI combined with gemcitabine and oxaliplatin GEMOX in the first-line treatment of patients with advanced biliary tract malignancies
Subjects will be screened to receive Adebrelimab and TKI in combination with Gemcitabine and Oxaliplatin GEMOX after they are fully informed and sign the informed consent Study treatment will continue until the subject develops intolerable toxicity withdraws informed consent and progresses as determined by the investigator in accordance with RECIST v11 when the subject develops disease progression as defined in RECIST v11 if the investigator assesses that the subject continues to have clinical benefit and can tolerate the study treatment The subject may continue treatment with the study drug treatment may be terminated if the subject is no longer considered to have a clinical benefit or other termination criteria specified in the protocol whichever occurs first
After the subjects were enrolled in the study the safety visit will be conducted in D1 of each treatment cycle and the safety visit and survival follow-up will be continued after the treatment
Tumor imaging evaluation Imaging examination was performed every 6 weeks after enrollment to evaluate the efficacy Additional imaging studies and evaluations may be performed at any time during the study if clinically indicated Imaging evaluation of the tumor will continue until disease progression is confirmed by the investigator according to the RECIST v11 criteria or treatment is discontinued whichever occurs later Subjects who ended treatment for reasons other than investigator-confirmed disease progression per RECIST v11 will also continue to be followed up at regular intervals for tumor imaging evaluation after the end of treatment
If the subject withdraws the knowledge has started other anti-tumor treatment except Chinese patent medicine or dies before the disease progression or termination of treatment confirmed by the investigator according to RECIST11 criteria there is no need to continue the imaging evaluation If the subject fails to meet the above termination criteria for imaging evaluation the tumor efficacy evaluation of other efficacy evaluation criteria RECIST v11 imRECIST still needs to be continued even if the disease progression of a certain efficacy evaluation criteria occurs
Subjects will be screened to receive Adebrelimab and TKI in combination with Gemcitabine and Oxaliplatin GEMOX after they are fully informed and sign the informed consent Study treatment will continue until the subject develops intolerable toxicity withdraws informed consent and progresses as determined by the investigator in accordance with RECIST v11 when the subject develops disease progression as defined in RECIST v11 if the investigator assesses that the subject continues to have clinical benefit and can tolerate the study treatment The subject may continue treatment with the study drug treatment may be terminated if the subject is no longer considered to have a clinical benefit or other termination criteria specified in the protocol whichever occurs first
After the subjects were enrolled in the study the safety visit will be conducted in D1 of each treatment cycle and the safety visit and survival follow-up will be continued after the treatment
Tumor imaging evaluation Imaging examination was performed every 6 weeks after enrollment to evaluate the efficacy Additional imaging studies and evaluations may be performed at any time during the study if clinically indicated Imaging evaluation of the tumor will continue until disease progression is confirmed by the investigator according to the RECIST v11 criteria or treatment is discontinued whichever occurs later Subjects who ended treatment for reasons other than investigator-confirmed disease progression per RECIST v11 will also continue to be followed up at regular intervals for tumor imaging evaluation after the end of treatment
If the subject withdraws the knowledge has started other anti-tumor treatment except Chinese patent medicine or dies before the disease progression or termination of treatment confirmed by the investigator according to RECIST11 criteria there is no need to continue the imaging evaluation If the subject fails to meet the above termination criteria for imaging evaluation the tumor efficacy evaluation of other efficacy evaluation criteria RECIST v11 imRECIST still needs to be continued even if the disease progression of a certain efficacy evaluation criteria occurs
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None