SIB-RT Combined With CAPOX and PD-1 for High-Risk Rectal Cancer

Phase 2Not Yet RecruitingNCT07297030

Sun Yat-sen University37 enrolled

Overview

The biological effective dose of short-course radiotherapy is relatively lower compared to long-course radiotherapy, which may lead to an increased local recurrence rate in patients with mid to low rectal cancer who are at high risk of locally advanced disease due to insufficient radiation dose. Combining short-course radiotherapy with simultaneous integrated boost (SIB) and immunotherapy-chemo regimens could potentially further enhance tumor regression and improve local control, providing a promising treatment option for high-risk locally advanced rectal cancer patients. Therefore, this clinical trial aims to explore the safety and effectiveness of a short-course SIB radiotherapy regimen combined with immunotherapy and chemotherapy as neoadjuvant treatment for locally advanced rectal cancer, based on short-course radiotherapy combined with chemotherapy and immunotherapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rectal Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants must voluntarily agree to join this study and sign an informed consent form. * Age at the time of signing the informed consent form must be between 18 and 75 years. * Histologically confirmed diagnosis of rectal adenocarcinoma. * High-risk locally advanced pMMR/MSS rectal cancer, categorized according to the AJCC/UICC 8th edition clinical staging and in reference to the inclusion criteria of the RAPIDO study, must meet at least one of the following conditions: cT4 stage, cN2 stage, involvement of the mesorectal fascia (MRF), or presence of laterally enlarged lymph nodes, with M0 status. * The inferior margin of the tumor must be ≤10 cm from the anal verge. * No prior anti-cancer treatment for rectal cancer (including local-regional and systemic therapy). * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1. * At least one measurable lesion according to RECIST v1.1 criteria. * Normal function of major organs without severe abnormalities in hematological, cardiovascular, pulmonary, hepatic, renal, or bone marrow function; laboratory tests must meet the following requirements: Hemoglobin (Hb) ≥ 70 g/L; White blood cell count (WBC) ≥ 3.0 × 10\^9/L; Neutrophil count (NEUT) ≥ 1.5 × 10\^9/L; Platelet count (PLT) ≥ 100 × 10\^9/L; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤ 2.5 times the upper limit of normal (ULN); Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); Renal function (serum creatinine, sCr) level ≤ 1.5 times the upper limit of normal (ULN). Exclusion Criteria: * Evidence of distant metastasis. * Recurrent rectal cancer. * Documented allergy to the investigational drug and/or its excipients. * Contraindications to radiotherapy and/or chemotherapy. * Women who are pregnant or breastfeeding. * A history of other malignancies. * Patients who have participated in other clinical trials involving investigational drugs within the last 6 months. * Patients deemed inappropriate for inclusion in this study as determined by the investigator.

Outcomes

Primary Outcomes

The Complete Response (CR) rate

The Complete Response (CR) rate refers to the sum of the pathological Complete Response (pCR) rate, defined as the absence of residual cancer cells in the surgical resection specimen observed microscopically, and the probability of patients achieving clinical Complete Response (cCR) who then undergo a watchful waiting (W\&W) approach. The primary endpoint of my study is the CR rate.

Time frame: 3 months

Secondary Outcomes

Rate of ≥Grade 3 toxicities

This endpoint measures the incidence of adverse events classified as Grade 3 or higher according to the Common Terminology Criteria for Adverse Events (CTCAE). A Grade 3 toxicity indicates a severe reaction that significantly affects the patient's daily activities and typically requires medical intervention. Monitoring the rate of these serious toxicities will help evaluate the safety profile of the treatment regimen, including neoadjuvant short-course radiotherapy combined with simultaneous integrated boost, immunotherapy, and chemotherapy, in patients with high-risk locally advanced rectal cancer. Assessing these toxicities is critical for understanding the balance between therapeutic efficacy and tolerability in this patient population.

Time frame: 3 months

3-Year Disease-Free Survival Rate (3yDFS%)

The 3-Year Disease-Free Survival Rate (3yDFS%) refers to the percentage of patients who do not experience any disease progression within three years after completing the treatment.

Time frame: 3 years

3-Year Locoregional Recurrence-Free Survival Rate (3yLRFS%)

The 3-Year Locoregional Recurrence-Free Survival Rate (3yLRFS%) is defined as the percentage of patients who remain free from locoregional recurrence of cancer for three years after completing the treatment.

Time frame: 3 years

3-Year Overall Survival Rate (3yOS%)

This endpoint refers to the percentage of patients who are still alive three years after receiving the treatment, regardless of disease status.

Time frame: 3 years

Surgical Complications

This endpoint assesses the occurrence of adverse events related to the surgical procedure performed on patients with high-risk locally advanced rectal cancer. Surgical complications may include infections, bleeding, anastomotic leaks, and any other significant morbidity that may influence the patient's postoperative recovery.

Time frame: 6 months

Quality of Life (QoL)

This endpoint evaluates the overall well-being of patients following treatment, focusing on their physical, emotional, and social health. Quality of Life assessments will be performed using validated questionnaires, such as the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). This scale comprises multiple dimensions, including physical functioning, emotional functioning, and social functioning, with scores ranging from 0 to 100, where higher scores indicate better quality of life. The assessments will provide insights into patients' functional status and any changes in health-related quality of life resulting from the treatment regimen. Understanding QoL outcomes is essential for assessing the patient-centered effectiveness of the therapeutic approach and ensuring that treatment strategies not only target disease control but also support the overall well-being of patients.

Time frame: 3 years

SIB-RT Combined With CAPOX and PD-1 for High-Risk Rectal Cancer

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts