Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer
Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer --- a Multicenter Randomized Controlled Trial (CINTS-R)
Peking Union Medical College Hospital
470 participants
Feb 3, 2023
INTERVENTIONAL
Conditions
Summary
Rectal cancer still remains one of the most popular tumors, however, distance metastasis still remains as high as 30% and the long-term survival outcomes are still unsatisfying. The recent conception of total neoadjuvant therapy and immune therapy is becoming popular and the oncologic effects are encouraging, especially in terms of circulating tumor DNA (ctDNA), the prognostic value of ctDNA has been demonstrated by our prior study. This study will carry out accurate ctDNA-guided neoadjuvant therapy on the basis of previous studies of the research group, and give appropriate treatment plans and treatment intensity to patients with different disease degrees. At the same time, combined with the latest progress in clinical diagnosis and treatment, the potential beneficiaries of immunotherapy were screened scientifically, and the combined immunotherapy was implemented accordingly.
Eligibility
Inclusion Criteria8
- Aged 18-75 years;
- ECOG score 0-2;
- Rectal adenocarcinoma confirmed by pathology;
- The lower margin of the tumor was less than 12cm from the anal margin;
- Patients with clinical stage cT3-4N0M0 or cTanyN+M0;
- Newly treated patients who have not received treatment including radiotherapy, chemotherapy and surgery;
- Liver, kidney and other organs have good function and can tolerate radiotherapy, chemotherapy and surgery;
- Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent.
Exclusion Criteria9
- ECOG score \> 2;
- Patients with multiple primary colorectal cancers;
- A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years;
- Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery;
- pregnant or lactating women;
- Patients with a history of severe mental illness, immune disease, hormone medication;
- Patients contraindicated by MRI examination, chemoradiotherapy, immunotherapy or surgery;
- Participated in other clinical researchers in the past 3 months;
- Any other circumstances that the investigator considers inappropriate for inclusion.
Interventions
This study will further testify the prognostic value of ctDNA in the treatment term of locally advanced rectal cancer, the higher the VAF value, the higher the risk of recurrence and metastasis.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05601505