Feasibility of ctDNA-guided precision neoadjuvant therapy in locally advanced rectal cancer: Insights from the ongoing CINTS-R trial.
Xiao Zhang, Jiaolin Zhou, Jianhao Geng...
https://pubmed.ncbi.nlm.nih.gov/41435753Actively Recruiting
Phase 2
Age: 18Years - 75Years
All Genders
ID05601505
Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer - a Multicenter Randomized Controlled Trial (CINTS-R)
Led by Peking Union Medical College Hospital · Updated on 2024-12-24
470
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Locally advanced rectal cancer remains a common tumor with a high rate of distant metastasis and unsatisfactory long-term survival. Researchers are evaluating a new treatment approach using circulating tumor DNA (ctDNA) to guide neoadjuvant therapy intensity and immunotherapy use. This phase 2 multicenter randomized trial aims to improve treatment precision and outcomes by tailoring therapy based on ctDNA tumor burden and genetic markers. Participants with rectal adenocarcinoma staged as cT3-4N0 or cTanyN+ are randomized into two groups. The control group receives traditional neoadjuvant chemoradiotherapy with oral capecitabine and radiotherapy. The experimental group receives treatment guided by ctDNA variant allele frequency (VAF) and genetic sequencing, including immunotherapy with Terelizumab for patients with MSI-H or TMB-H mutations, or neoadjuvant chemoradiotherapy or total neoadjuvant therapy based on ctDNA levels. Throughout the study, participants will undergo tumor tissue sequencing, immune marker analysis, and regular assessments including clinical complete response, pathological response, survival, and quality of life over up to 5 years. The primary outcome is two-year disease-related treatment failure. Safety, recurrence, and other outcome measures will also be monitored. The study seeks to optimize treatment plans and reduce adverse effects by using precision medicine guided by ctDNA.
CONDITIONS
Brief Title
Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18-75 years
- ECOG score 0-2
- Pathologically confirmed rectal adenocarcinoma
- Tumor lower margin less than 12 cm from the anal margin
- Clinical stage cT3-4N0M0 or cTanyN+M0
- Newly diagnosed patients with no prior radiotherapy, chemotherapy, or surgery
- Good liver, kidney, and other organ function to tolerate treatments
- Ability to understand the study and provide informed consent
You will not qualify if you...
- ECOG score greater than 2
- Multiple primary colorectal cancers
- History of other malignant tumors within past 5 years, except certain cured cancers
- Conditions requiring emergency surgery such as intestinal obstruction or perforation
- Pregnant or lactating women
- History of severe mental illness, immune disease, or hormone medication use
- Contraindications to MRI, chemoradiotherapy, immunotherapy, or surgery
- Participation in other clinical trials within past 3 months
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessment
Treatment
Duration - Approximately 12 to 24 weeks depending on treatment group
Participants receive neoadjuvant therapy based on ctDNA results or standard chemoradiotherapy. This includes radiotherapy and chemotherapy, with some participants receiving immune therapy depending on specific tumor markers.
Multiple visits for radiotherapy and chemotherapy sessions over several weeks
Follow-up
Duration - Up to 2 years
Participants are monitored for up to 2 years to assess treatment effectiveness and survival outcomes.
Periodic visits for assessments during follow-up period
Trial Site Locations
Total: 1 location
1
Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences,
Beijing, Beijing Municipality, China, 100005
Actively Recruiting
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Research Team
L
Lin guole, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Rationale and design of a multicentre randomised controlled trial on circulating tumour DNA-guided neoadjuvant treatment strategy for locally advanced rectal cancer (CINTS-R).
Jiaolin Zhou, Xiao Zhang, Qian Liu...
https://pubmed.ncbi.nlm.nih.gov/39894522