Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer
Recruiting now · Phase 2
Conditions studied: Locally Advanced Rectal Carcinoma, Circulating Tumor DNA
In brief
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.
Key facts
- Study ID
- NCT05601505
- Run by
- Peking Union Medical College Hospital
- People needed
- 470
- Starts
- 2023-02-03
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2024-12-24
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, — Beijing, Beijing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.