Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bev… (NCT06872606) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Short-Course Radiotherapy Combined with Intracavitary Brachytherapy Followed by Pucotenlimab, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil (TAS-102) for Total Neoadjuvant Therapy of Microsatellite Stable (MSS) Locally Advanced Low Rectal Cancer
China33 participantsStarted 2025-04-01
Plain-language summary
A Prospective Single-Arm Study of Short-Course Radiotherapy Followed by PD-1 Monoclonal Antibody, Bevacizumab, Oxaliplatin, and Trifluridine/Tipiracil for Total Neoadjuvant Therapy in MSS Locally Advanced Low Rectal Cancer. This is a Non-Randomized, Single Group Assignment, Open Label, Phase: Phase II study. The Primary Objective is to assess the organ preservation rate (clinical complete response, cCR) after total neoadjuvant therapy. Secondary Objectives are Tumor regression grade (TRG), 3-year overall survival (OS) and disease-free survival (DFS), and Safety and quality of life (QoL). In this study, the investigators will perform the multi-dimensional omics study to explore the tumors microenvironments, explore the characteristics of the treatment benefit population, and try to construct an efficacy prediction model to screen the treatment benefit population early and implement precise treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients who are willing to receive neoadjuvant therapy.
✓. ≧18 years old.
✓. Diagnosed by digital rectal examination, colonoscopy, and high-resolution MRI of the pelvis, the tumor is less than or equal to 5 cm from the anus.
✓. Histologically diagnosed as rectal adenocarcinoma.
✓. Clinical stage: cT2-4a N+ or cT3/T4a N0 (MRI/CT-confirmed).
✓. MSS/pMMR status confirmed by immunohistochemistry or PCR before treatment .
✓. ECOG Scale of Performance Status score 0-1 point.
✓. Adequate organ function (hematologic, hepatic, renal).
Exclusion criteria
✕. History of other malignant diseases in the past 5 years.
✕. Patients with metastases from other sites (stage IV patients).
What they're measuring
1
Organ preservation rate
Timeframe: Up to 2 weeks (once evaluation or biopsy is done)
. Patients withT4b or positive lateral lymph nodes by pelvic contrast-enhanced CT and pelvic high-resolution MRI.
✕. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. requiring emergency surgery.
✕. Known allergic to oxaliplatin, PD-1 monoclonal antibody and other intervention drugs.
✕. Pathologically suggested signet ring cell carcinoma and mucinous adenocarcinoma.
✕. dMMR or MSI-H patients.
✕. The patient is accompanied by any unstable systemic disease, including but not limited to: severe infection, uncontrolled diabetes, hypertension uncontrolled by medication, unstable angina, cerebrovascular accident or transient cerebral ischemia, myocardial Infarction, congestive heart failure, severe cardiac arrhythmia requiring medication, hepatic, renal or metabolic disease; disease affecting the patient's life.