Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 9:19 PM
Study NCT ID:
NCT07394192
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-06
First Post:
2026-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-III Rectal Cancer
Sponsor:
Peking University Cancer Hospital & Institute
Organization:
Study Overview
Official Title:
Exploratory Study on the Efficacy and Safety of Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-III Rectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-01
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:
PKUCH- R11
Brief Summary:
This study aims to evaluate the efficacy (pathological complete response rate) of short-course radiotherapy with preservation of tumor-draining lymph nodes followed by sequential PD-1 inhibitor neoadjuvant therapy in patients with stage II-III pMMR/MSS locally advanced rectal cancer.
Detailed Description:
This study is a single-arm, open-label exploratory clinical trial designed to investigate the feasibility and preliminary efficacy of a novel neoadjuvant treatment strategy for locally advanced rectal cancer. The strategy combines short-course radiotherapy (SCRT) with deliberate preservation of tumor-draining lymph nodes, followed by sequential PD-1 inhibitor therapy, with the aim of enhancing antitumor immune activation prior to definitive surgery. Given the exploratory nature of the study, no blinding will be applied, and both investigators and participants will be aware of the assigned treatment. Approximately 44 eligible patients are planned for enrollment.
The study is conducted across four sequential phases: screening and enrollment, neoadjuvant treatment, surgical intervention, and postoperative follow-up. During the screening phase, eligibility will be confirmed through histopathological evaluation, molecular testing, and standardized imaging assessments to establish disease stage and anatomical suitability for the protocol-defined treatment approach.
Neoadjuvant treatment begins with short-course radiotherapy administered in the first week after enrollment. Radiotherapy will be delivered using volumetric modulated arc therapy (VMAT) following standard procedures for patient positioning, immobilization, CT/MRI simulation, target volume delineation, treatment planning, and image-guided verification. In contrast to conventional pelvic irradiation, the clinical target volume is intentionally limited to the primary rectal tumor, excluding tumor-draining lymph nodes and elective pelvic nodal regions, in order to preserve regional immune structures. The prescribed dose is 25 Gy delivered in five fractions over five consecutive working days. Patients will be closely monitored for acute radiation-related toxicities, which will be graded and managed according to standard criteria.
Two weeks after completion of radiotherapy, patients will initiate immunotherapy. Sintilimab, a PD-1 inhibitor, will be administered intravenously at a fixed dose of 200 mg every three weeks for four cycles. Prior to each cycle, patients will undergo routine safety evaluations, including physical examination and laboratory testing, to assess treatment tolerance and determine eligibility for continued dosing. Treatment interruption, delay, or discontinuation will be guided by protocol-defined toxicity management rules.
A comprehensive restaging assessment will be performed approximately 2-4 weeks after completion of neoadjuvant therapy using standardized imaging modalities, including pelvic MRI and thoracoabdominal CT. Patients without evidence of disease progression will proceed to definitive surgical management. Radical resection with total mesorectal excision (TME) is required, with the specific surgical procedure selected according to tumor characteristics and individual clinical considerations.
Postoperative management will be determined based on pathological findings and multidisciplinary team discussion approximately one month after surgery. All patients will then enter a structured follow-up program lasting three years, with visits scheduled every three months. Follow-up evaluations will focus on disease status, survival outcomes, and the assessment of late treatment-related toxicities, using clinical examinations, laboratory tests, tumor markers, and imaging studies as clinically indicated.
The study is conducted across four sequential phases: screening and enrollment, neoadjuvant treatment, surgical intervention, and postoperative follow-up. During the screening phase, eligibility will be confirmed through histopathological evaluation, molecular testing, and standardized imaging assessments to establish disease stage and anatomical suitability for the protocol-defined treatment approach.
Neoadjuvant treatment begins with short-course radiotherapy administered in the first week after enrollment. Radiotherapy will be delivered using volumetric modulated arc therapy (VMAT) following standard procedures for patient positioning, immobilization, CT/MRI simulation, target volume delineation, treatment planning, and image-guided verification. In contrast to conventional pelvic irradiation, the clinical target volume is intentionally limited to the primary rectal tumor, excluding tumor-draining lymph nodes and elective pelvic nodal regions, in order to preserve regional immune structures. The prescribed dose is 25 Gy delivered in five fractions over five consecutive working days. Patients will be closely monitored for acute radiation-related toxicities, which will be graded and managed according to standard criteria.
Two weeks after completion of radiotherapy, patients will initiate immunotherapy. Sintilimab, a PD-1 inhibitor, will be administered intravenously at a fixed dose of 200 mg every three weeks for four cycles. Prior to each cycle, patients will undergo routine safety evaluations, including physical examination and laboratory testing, to assess treatment tolerance and determine eligibility for continued dosing. Treatment interruption, delay, or discontinuation will be guided by protocol-defined toxicity management rules.
A comprehensive restaging assessment will be performed approximately 2-4 weeks after completion of neoadjuvant therapy using standardized imaging modalities, including pelvic MRI and thoracoabdominal CT. Patients without evidence of disease progression will proceed to definitive surgical management. Radical resection with total mesorectal excision (TME) is required, with the specific surgical procedure selected according to tumor characteristics and individual clinical considerations.
Postoperative management will be determined based on pathological findings and multidisciplinary team discussion approximately one month after surgery. All patients will then enter a structured follow-up program lasting three years, with visits scheduled every three months. Follow-up evaluations will focus on disease status, survival outcomes, and the assessment of late treatment-related toxicities, using clinical examinations, laboratory tests, tumor markers, and imaging studies as clinically indicated.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: