Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06603402
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-13
Brief Title:
Low-Dose Involved-Field Radiotherapy Plus Immunochemotherapy for ESCC
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Low-Dose Involved-Field Radiotherapy Combined with Immunochemotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma a Prospective Single-Arm Phase II Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this clinical trial is to evaluate whether low-dose involved-field radiotherapy combined with immunochemotherapy can reduce treatment-related adverse effects enhance progression-free survival PFS and improve overall survival OS in patients with locally advanced unresectable esophageal squamous cell carcinoma
The key questions this study seeks to address are
Can low-dose involved-field radiotherapy combined with immunochemotherapy reduce treatment-related adverse effects
Does this combined approach improve PFS and OS in these patients
Participants in the study will
Undergo an endoscopy at West China Hospital to confirm their diagnosis
Receive a treatment regimen that includes low-dose radiotherapy at 50 Gy in 18 Gy per fraction over 25 fractions alongside immunochemotherapy with three cycles of chemotherapy administered every 3 weeks
After completing the full treatment regimen participants will undergo regular follow-up visits and monitoring by healthcare professionals
The key questions this study seeks to address are
Can low-dose involved-field radiotherapy combined with immunochemotherapy reduce treatment-related adverse effects
Does this combined approach improve PFS and OS in these patients
Participants in the study will
Undergo an endoscopy at West China Hospital to confirm their diagnosis
Receive a treatment regimen that includes low-dose radiotherapy at 50 Gy in 18 Gy per fraction over 25 fractions alongside immunochemotherapy with three cycles of chemotherapy administered every 3 weeks
After completing the full treatment regimen participants will undergo regular follow-up visits and monitoring by healthcare professionals
Detailed Description:
This is a single-arm single-center prospective clinical study aimed at evaluating the efficacy and safety of low-dose involved-field radiotherapy combined with immunochemotherapy in patients with locally advanced unresectable esophageal squamous cell carcinoma ESCC The study will enroll subjects with pathologically confirmed ESCC via histology or cytology clinically staged as cT1-4aNM0 who are deemed unsuitable for surgical intervention by the investigators or have declined surgical treatment
Initially patients will receive one cycle of induction immunochemotherapy consisting of paclitaxel or nab-paclitaxel plus carboplatin in combination with camrelizumab administered at 200 mg intravenously every three weeks On the first day of the second chemotherapy cycle low-dose involved-field radiotherapy will commence The radiotherapy protocol involves a total dose of 45 Gy delivered in 25 fractions of 18 Gy each 450 Gy18 Gy per fraction over 25 fractions The clinical target volume CTV is defined by extending the gross tumor volume GTV 3 cm superiorly and inferiorly and 05 cm anteriorly posteriorly and laterally for involved lymph nodes GTVn a 05 cm margin is added in all directions
Following disease stabilization patients will continue with maintenance therapy using camrelizumab monotherapy for up to one year or until disease progression as assessed by RECIST 11 criteria or the emergence of intolerable adverse effects Upon completion of treatment subjects will undergo routine follow-up according to standard care protocols to document survival status and long-term adverse reactions
The study utilizes a historical control one-year progression-free survival PFS rate of 34 from definitive chemoradiotherapy in locally advanced ESCC It is hypothesized that the combination of camrelizumab with dual-agent chemotherapy paclitaxel or nab-paclitaxel plus carboplatin and sequential low-dose involved-field radiotherapy will improve the 12-month PFS rate to 52 Based on a two-sided significance level α of 005 and a power 1-β of 80 the required sample size is calculated to be 37 patients Accounting for a 10 dropout rate a total of 41 patients will be enrolled in the study
Initially patients will receive one cycle of induction immunochemotherapy consisting of paclitaxel or nab-paclitaxel plus carboplatin in combination with camrelizumab administered at 200 mg intravenously every three weeks On the first day of the second chemotherapy cycle low-dose involved-field radiotherapy will commence The radiotherapy protocol involves a total dose of 45 Gy delivered in 25 fractions of 18 Gy each 450 Gy18 Gy per fraction over 25 fractions The clinical target volume CTV is defined by extending the gross tumor volume GTV 3 cm superiorly and inferiorly and 05 cm anteriorly posteriorly and laterally for involved lymph nodes GTVn a 05 cm margin is added in all directions
Following disease stabilization patients will continue with maintenance therapy using camrelizumab monotherapy for up to one year or until disease progression as assessed by RECIST 11 criteria or the emergence of intolerable adverse effects Upon completion of treatment subjects will undergo routine follow-up according to standard care protocols to document survival status and long-term adverse reactions
The study utilizes a historical control one-year progression-free survival PFS rate of 34 from definitive chemoradiotherapy in locally advanced ESCC It is hypothesized that the combination of camrelizumab with dual-agent chemotherapy paclitaxel or nab-paclitaxel plus carboplatin and sequential low-dose involved-field radiotherapy will improve the 12-month PFS rate to 52 Based on a two-sided significance level α of 005 and a power 1-β of 80 the required sample size is calculated to be 37 patients Accounting for a 10 dropout rate a total of 41 patients will be enrolled in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None