Ignite Creation Date:
2024-05-06 @ 6:16 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05608785
Status:
UNKNOWN
Last Update Posted:
2022-11-08
First Post:
2022-09-15
Brief Title:
Single-center Multi-cohort Exploratory Phase IbII Clinical Study of First-line Treatment of Unresectable Locally AdvancedAdvanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes
Sponsor:
Henan Cancer Hospital
Organization:
Henan Cancer Hospital
Study Overview
Official Title:
Single-center Multi-cohort Exploratory Phase IbII Clinical Study of First-line Treatment of Unresectable Locally AdvancedAdvanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
NOT_YET_RECRUITING
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:
Abstract Study title Single-center Multi-cohort Exploratory Phase IbII Clinical Study of First-line Treatment of Unresectable Locally AdvancedAdvanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Based on Different Genotypes Protocol No GC-MATCH Initiator Henan Cancer Hospital Nature of study Investigator-initiated exploratory study Subjects Advanced first-line gastric cancer or adenocarcinoma of the gastroesophageal junction Objective To evaluate the efficacy and safety of different first-line treatment options for unresectable locally advancedadvanced gastric or combined gastroesophageal adenocarcinoma with different geneprotein types
Evaluation criteria To evaluate the adverse effects of drugs using the NCI CTCAE V50 criteria
RECIST11 criteria were used to evaluate drug efficacy Study endpoints Primary indicators Objective Response Rate ORR Secondary indicators 1 drug safety 2 disease control rate DCR CRPRSD 3 duration of remission DoR 4 disease-free survival PFS and overall survival time OS 5 R0R1 surgical resection rate Study design Single-center umbrella clinical trial Planned number of enrollment Total 39-45 cases Sample size estimation This is an exploratory study and sample size was not calculated Statistical methods Selection of data for statistical analysis Full Analysis Set FAS The efficacy analysis was performed on all patients who were enrolled and used the drug at least once according to the principle of intentional analysis ITT
Per-protocol Set Cases with at least one oncologic efficacy assessment compliance with the trial protocol good compliance no prohibited drugs during the trial and completion of the case report form
Safety Analysis Set All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set
Statistical analysis plan Validity analysis for the efficacy index PFS the Kaplan-Meier method will be used to estimate its median time and column Statistical methods Out of two-sided 95 confidence intervals Disease control rate DCR CRPRSD and objective remission rate ORR CRPR were calculated using Fisher exact probability and bilateral 95 confidence intervals were presented
Safety analysis descriptive statistical analysis was used to tabulate the AEs that occurred in this trial laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred
Treatment protocol
All subjects in this study were first tested for genesproteins HER2 protein HER2FISH PD-L1 protein 22C3 Claudin182 MMR and received treatment in different groups according to geneprotein expression
Group 1 HER protein positive 3 or FISH amplification or HER protein 2 but FISH amplification Initial treatment 4-6 cycles IBI315 injection oxaliplatin capecitabine Group 2 Claudin182 protein-positive Initial treatment 4-6 cycles PD-L1 monoclonal antibody TST001 injection oxaliplatin capecitabine Group 3 Her protein and Claudin182 protein were negative Initial treatment 4-6 cycles TQB2450 injection Anrotinib Oxaliplatin Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation The duration of maintenance treatment was 2 years from the time of enrollment
Principal Investigator Luo Suxia Li Ning Group leader unit Henan Cancer Hospital
Evaluation criteria To evaluate the adverse effects of drugs using the NCI CTCAE V50 criteria
RECIST11 criteria were used to evaluate drug efficacy Study endpoints Primary indicators Objective Response Rate ORR Secondary indicators 1 drug safety 2 disease control rate DCR CRPRSD 3 duration of remission DoR 4 disease-free survival PFS and overall survival time OS 5 R0R1 surgical resection rate Study design Single-center umbrella clinical trial Planned number of enrollment Total 39-45 cases Sample size estimation This is an exploratory study and sample size was not calculated Statistical methods Selection of data for statistical analysis Full Analysis Set FAS The efficacy analysis was performed on all patients who were enrolled and used the drug at least once according to the principle of intentional analysis ITT
Per-protocol Set Cases with at least one oncologic efficacy assessment compliance with the trial protocol good compliance no prohibited drugs during the trial and completion of the case report form
Safety Analysis Set All patients who had used the trial drug at least once and had a safety record after the drug was administered were enrolled in the Safety Analysis Set
Statistical analysis plan Validity analysis for the efficacy index PFS the Kaplan-Meier method will be used to estimate its median time and column Statistical methods Out of two-sided 95 confidence intervals Disease control rate DCR CRPRSD and objective remission rate ORR CRPR were calculated using Fisher exact probability and bilateral 95 confidence intervals were presented
Safety analysis descriptive statistical analysis was used to tabulate the AEs that occurred in this trial laboratory test results were described as normal before the trial but abnormal after treatment and in relation to the trial drug when abnormal changes occurred
Treatment protocol
All subjects in this study were first tested for genesproteins HER2 protein HER2FISH PD-L1 protein 22C3 Claudin182 MMR and received treatment in different groups according to geneprotein expression
Group 1 HER protein positive 3 or FISH amplification or HER protein 2 but FISH amplification Initial treatment 4-6 cycles IBI315 injection oxaliplatin capecitabine Group 2 Claudin182 protein-positive Initial treatment 4-6 cycles PD-L1 monoclonal antibody TST001 injection oxaliplatin capecitabine Group 3 Her protein and Claudin182 protein were negative Initial treatment 4-6 cycles TQB2450 injection Anrotinib Oxaliplatin Capecitabine Patients can undergo radical gastric cancer surgery or radical gastric cancer surgery local treatment during the maintenance treatment phase if their condition is stable and after in-hospital MDT consultation The duration of maintenance treatment was 2 years from the time of enrollment
Principal Investigator Luo Suxia Li Ning Group leader unit Henan Cancer Hospital
Detailed Description:
None
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