A Phase 2 interventional study of moderately hypofractionated radiotherapy and chemotherapy in Rectal Cancer, sponsored by Shanghai Zhongshan Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Shanghai Zhongshan Hospital · Phase 2, Interventional, and Treatment
This study aims to evaluate the effectiveness and safety of combining moderately hypofractionated radiotherapy with chemotherapy and anti-PD-1 antibodies as a neoadjuvant treatment for high-risk locally advanced rectal cancer.
This study investigates a novel treatment approach involving moderately hypofractionated radiotherapy (3-3.5Gy×10) combined with chemotherapy and immunotherapy for patients with high-risk locally advanced rectal adenocarcinoma, aiming to optimize treatment efficacy and patient outcomes.
Neoadjuvant chemoradiotherapy followed by total mesorectal excision (TME) is the standard of care for locally advanced rectal cancer, improving surgical resection rates, local control, and sphincter preservation. Conventional long-course radiotherapy is the standard modality for neoadjuvant therapy, but it has drawbacks such as long treatment duration, high cost, and prolonged preoperative waiting time. Short-course radiotherapy, on the other hand, offers shorter treatment duration, lower cost, and shorter preoperative waiting time, but it is associated with higher rates of local recurrence. Immunotherapy has demonstrated promising anti-tumor activity in colorectal cancers with deficient mismatch repair (dMMR) and/or microsatellite instability-high (MSI-H) status, but its role in proficient mismatch repair (pMMR) and/or microsatellite stable (MSS) colorectal cancers remains unclear. However, studies have shown that the combination of chemoradiotherapy and immunotherapy can increase the pathologic complete response rate compared to chemoradiotherapy alone, suggesting that radiotherapy may serve as a stimulator of adaptive immunity and synergize with immunotherapy. Therefore, this study aims to explore the following regimen: neoadjuvant moderately hypofractionated radiotherapy at a dose of 3.5 Gy × 10 fractions to the tumors and 3 Gy × 10 fractions to the pelvic lymph node drainage area, combined with chemotherapy (capecitabine and oxaliplatin) and immunotherapy (Serplulimab).
This prospective, single-center, non-randomized Phase II trial is designed to explore the efficacy and safety of the treatment regimen. Patients will receive CapeOx chemotherapy, anti-PD-1 monoclonal antibody immunotherapy, and a course of moderately hypofractionated radiotherapy. The trial protocol prioritizes safety monitoring and efficacy assessments through standardized clinical and imaging evaluations.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's planned enrollment of 54 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This study examines combined radiotherapy, chemotherapy, and immunotherapy for high-risk locally advanced rectal cancer. After a week post-radiotherapy, patients start CapeOx chemotherapy with anti-PD-1 mAb. Surgery follows after 3 cycles of this regimen.
Radiation: moderately hypofractionated radiotherapy · Drug: chemotherapy · Drug: immunotherapy · Procedure: Total mesorectal excision (TME) surgery
35 Gy in 10 fractions to mesorectal and metastatic lymph nodes, and 30 Gy in 10 fractions to pelvic lymphatic drainage area, weekly over 5 days at 3-3.5 Gy/day.
CapeOx-Capecitabine 1000 mg/m² orally twice daily (days 1-14, every 21 days) + Oxaliplatin 130 mg/m² IV (day 1, every 21 days).
Serplulimab 300 mg IV infusion on day 1 every 21 days.
Total mesorectal excision (TME) surgery assessment post 3 cycles of chemotherapy and immunotherapy; eligible patients undergo TME surgery.
pathologic complete response (pCR)
Proportion of patients in whom no cancer cells are found in resected rectal tissue and regional lymph nodes upon pathological evaluation.
Time frame: 30-day
disease-free survival (DFS)
DFS is defined as the time from randomization until disease recurrence or death from any cause.
Time frame: 3-year
event-free survival (EFS)
Time from treatment initiation to occurrence of any of the following: disease progression affecting surgery, post-operative disease progression or recurrence, or death from any cause.
Time frame: 3-year
objective response rate (ORR)
Proportion of patients showing partial or complete response to treatment, defined by RECIST v1.1 as ORR=(CR+PR)/ITT\*100%.
Time frame: 3-month
overall survival (OS)
OS is defined as the time from randomisation to death.
Time frame: 3-year
adverse events
Incidence of adverse events: According to CTCAE 5.0.
Time frame: 3-year
Quality of Life (QoL)-LARS socre
LARS score questionnaire: A tool used to assess bowel function and quality of life after rectal surgery, focusing on symptoms like frequency of bowel movements, urgency, and incontinence. The score ranges from 0 to 42, with higher scores indicating more severe symptoms and a greater impact on quality of life.
Time frame: 3-year
Quality of Life (QoL)-Wexner score
Wexner score: Wexner score composed of five items (solid, liquid, gas, wears pad, and lifestyle alteration) and five frequencies, resulting in a total score ranging from 0 (perfect continence) to 20 (complete incontinence). The score includes pad usage and lifestyle alteration, providing a comprehensive assessment of the impact of fecal incontinence on a patient\'s daily life
Time frame: 3-year
Quality of Life (QoL)-FISI score
FISI score: The Fecal Incontinence Severity Index, a questionnaire that quantifies the impact of fecal incontinence on quality of life by assessing the frequency of incontinence episodes and related concerns. It includes four types of incontinence (gas, mucus, liquid, solid) and six frequencies, plus a \"never\" option. Each item is scored according to its frequency, and the total score ranges from 0 to 61, with higher scores indicating greater severity and impact on the patient\'s life.
Time frame: 3-year
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Zhongshan Hospital