Ignite Creation Date:
2024-05-06 @ 7:37 PM
Last Modification Date:
2024-10-26 @ 3:10 PM
Study NCT ID:
NCT06076135
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2023-09-28
Brief Title:
Intestinal Low Dose Radiotherapy Combined With Immunotherapy in Immune-resistant Metastatic Solid Tumors
Sponsor:
Chuangzhen Chen
Organization:
Shantou University Medical College
Study Overview
Official Title:
Efficacy and Safety of Combining Intestinal Low Dose Radiotherapy and PD-1PD-L1 Inhibitors for Metastatic Malignant Solid Tumors After Acquired Resistance to Anti-PD1PD-L1 Treatment
Status:
RECRUITING
Status Verified Date:
2024-10
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:
ILDR-01
Brief Summary:
Preclinical and clinical studies have shown that intestinal low dose radiotherapy ILDR can enhance antitumor immunity and response to immune checkpoint blockade ICB Therefore the investigators launch a phase Ⅱ trial to evaluate the clinical value of combining ILDR and programmed cell death-1 -ligand 1 PD-1PD-L1 inhibitors in patients with ICB refractory metastatic solid tumor
This study is designed as a researcher-initiated two-stage and prospective clinical trial The target population is patients with advanced metastatic malignant solid tumors who have progressed after immunotherapy The primary endpoints include objective response rate ORR disease control rate DCR progression free survival while receiving ILDR combined therapy PFS2 and lesion-based abscopal response rate The secondary endpoints include incidence of adverse events AEs cancer-specific survival CSS and overall response rate OS
In the treatment stage Ⅰ sixteen subjects will be enrolled in this trial The primary objective of this stage is to evaluate the safety and efficacy of 1Gy ILDR combined with PD-1PD-L1 inhibitors in immune-resistant metastatic malignant solid tumors and biomarker exploration for response prediction
The inclusion criteria exclusion criteria and sample size for treatment stage Ⅱ will be modified on the basis of results from Stage Ⅰ The objective of the stage Ⅱ is to determine effects and safety of various dosage regimen of ILDR combined with PD-1PD-L1 inhibitors in target patients
Eligible patients will be subjected to 1-3Gy ILDR Tumor response will be assessed according to Response Evaluation Criteria in Solid Tumors RECIST 11 as well as Immune related RECIST iRECSIST The extent or severity of adverse reactions will be assessed using Common Terminology Criteria for Adverse Events CTCAE version 50 Furthermore tissue samples stool samples and peripheral blood samples will be collected for biomarker exploration
This study is designed as a researcher-initiated two-stage and prospective clinical trial The target population is patients with advanced metastatic malignant solid tumors who have progressed after immunotherapy The primary endpoints include objective response rate ORR disease control rate DCR progression free survival while receiving ILDR combined therapy PFS2 and lesion-based abscopal response rate The secondary endpoints include incidence of adverse events AEs cancer-specific survival CSS and overall response rate OS
In the treatment stage Ⅰ sixteen subjects will be enrolled in this trial The primary objective of this stage is to evaluate the safety and efficacy of 1Gy ILDR combined with PD-1PD-L1 inhibitors in immune-resistant metastatic malignant solid tumors and biomarker exploration for response prediction
The inclusion criteria exclusion criteria and sample size for treatment stage Ⅱ will be modified on the basis of results from Stage Ⅰ The objective of the stage Ⅱ is to determine effects and safety of various dosage regimen of ILDR combined with PD-1PD-L1 inhibitors in target patients
Eligible patients will be subjected to 1-3Gy ILDR Tumor response will be assessed according to Response Evaluation Criteria in Solid Tumors RECIST 11 as well as Immune related RECIST iRECSIST The extent or severity of adverse reactions will be assessed using Common Terminology Criteria for Adverse Events CTCAE version 50 Furthermore tissue samples stool samples and peripheral blood samples will be collected for biomarker exploration
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