Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06364384
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2024-04-02
Brief Title:
Radical Concurrent Chemoradiotherapy With DDP5-FU and PD-1 Antibody for Non-metastatic Rectal Squamous Cell Carcinoma
Sponsor:
Sixth Affiliated Hospital Sun Yat-sen University
Organization:
Sixth Affiliated Hospital Sun Yat-sen University
Study Overview
Official Title:
Radical Concurrent Chemoradiotherapy With DDP5-FU and PD-1 Antibody for Newly Diagnosed Non-metastatic Rectal Squamous Cell Carcinoma A Multicenter Prospective Single Arm Phase II StudyRICH
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma rSCC lt will also learn about the safety of the regime The main questions it aims to answer are
Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis What is the complete response rate CCR of the regime Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs
Participants will receive chemotherapy with DDP and 5-FU immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY
Does PD-1 monoclonal antibody combined with radical chemoradiotherapy improve survival prognosis What is the complete response rate CCR of the regime Researchers will compare PD-1 monoclonal antibody combined with radical chemoradiotherapy to previous study to see if this regime works to treat rSCCs
Participants will receive chemotherapy with DDP and 5-FU immunotherapy with PD-1 monoclonal antibody and radiotherapy with a total dose of 50-54GY
Detailed Description:
Rectal squamous cell cancer rSCC is a rare malignancy and its incidence is increasing year by year Due to the rarity of rSCC there is no consensus on its epidemiology pathogenesis prognosis and treatment management Due to the limitation of clinical data there is an urgent need for further clinical exploration and research
In recent years the combination of CRT and immunotherapy has attracted more and more attention as they may have more advantages over CRT aloneA number of prospective clinical trials of PD-1 monoclonal antibody combined with CRT for the first-line treatment of advanced aSCC are also underway NCT03233711 NCT04230759 NCT05661188 NCT05374252 etc Similarly the efficacy and safety of PD-1 monoclonal antibody in rSCC patients are also worthy of further discussion in order to further improve the survival prognosis of rSCC patients Our previous study data showed that the 3-year OS and DFS of radical CRT were 889 and 667 respectively for non-metastatic rSCC and 100 and DFS for radical CRT combined with immunotherapy respectively and CRT combined with immunotherapy significantly improved survival compared with radical CRT P002
The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma rSCC lt will also learn about the safety of the regime Therefore we plan to conduct a multicenter prospective single-arm phase II study to provide evidence-based medical evidence for the treatment of locally advanced rectal squamous cell carcinoma
The primary outcome is 1-year tumor-free survival DFS and the secondary outcomes are including 1-year overall survival OS 1-year relapse-free survival RFS 1-year metastasis free survival DMFS 1-year stoma-free survival incidence of chemotherapy and immunotherapy-related adverse reactions and complete response rate CRR
Participants will receive interventions below
1 Chemotherapy 3w aDDP 75 mgm2 d1 intravenous infusion b5-FU 1000 mgm2 d1-4 continuous pumping intravenously
2 Immunotherapy 3w PD-1 monoclonal antibodysintlimab 200mg d1 intravenous infusion
3 Radiotherapy at 3rd week after firstime of chemotherapyDaily single dose of 2Gy with a total dose of 50-54GY
In recent years the combination of CRT and immunotherapy has attracted more and more attention as they may have more advantages over CRT aloneA number of prospective clinical trials of PD-1 monoclonal antibody combined with CRT for the first-line treatment of advanced aSCC are also underway NCT03233711 NCT04230759 NCT05661188 NCT05374252 etc Similarly the efficacy and safety of PD-1 monoclonal antibody in rSCC patients are also worthy of further discussion in order to further improve the survival prognosis of rSCC patients Our previous study data showed that the 3-year OS and DFS of radical CRT were 889 and 667 respectively for non-metastatic rSCC and 100 and DFS for radical CRT combined with immunotherapy respectively and CRT combined with immunotherapy significantly improved survival compared with radical CRT P002
The goal of this clinical trial is to learn if PD-1 monoclonal antibody combined with radical chemoradiotherapy works to treat rectal squamous cell carcinoma rSCC lt will also learn about the safety of the regime Therefore we plan to conduct a multicenter prospective single-arm phase II study to provide evidence-based medical evidence for the treatment of locally advanced rectal squamous cell carcinoma
The primary outcome is 1-year tumor-free survival DFS and the secondary outcomes are including 1-year overall survival OS 1-year relapse-free survival RFS 1-year metastasis free survival DMFS 1-year stoma-free survival incidence of chemotherapy and immunotherapy-related adverse reactions and complete response rate CRR
Participants will receive interventions below
1 Chemotherapy 3w aDDP 75 mgm2 d1 intravenous infusion b5-FU 1000 mgm2 d1-4 continuous pumping intravenously
2 Immunotherapy 3w PD-1 monoclonal antibodysintlimab 200mg d1 intravenous infusion
3 Radiotherapy at 3rd week after firstime of chemotherapyDaily single dose of 2Gy with a total dose of 50-54GY
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