Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
circulating tumor DNA
Other interventionThis 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.
Treatment groups
470 Participants
are divided into 2 treatment groupsGroup A: Traditional neoadjuvant chemoradiotherapy groupNo intervention 0 interventions
Group B: ctDNA-guided neoadjuvant treatment groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
two-year disease-related treatment failure, 2y-DrTF
the incidence of any of the following events occurring after treatment: identification of distant metastasis or progression to unresectable disease before surgery, non-radical resection of the primary tumour, local recurrence or distant metastasis after radical surgery, new primary colorectal tumour, or treatment-related death.
Time frame
2 yearsSecondary outcomes
1
Time to recurrence, TTR
The median time from randomization to the first observation of recurrence.
Time frame
2 years2
Two-year overall survival, 2yOS
Refers to the proportion of patients still alive at 2 years after surgery
Time frame
2 years3
two-year disease-free survival (2yDFS)
the percentage of patients who remain free of cancer recurrence or death from any cause two years after surgery.
Time frame
2 years4
clinical complete response (cCR) and near complete response (ncCR) rate
cCR and ncCR rate evaluated based on comprehensive examinations according to NCCN guidelines.
Time frame
up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov