Rectal Cancer Neoadjuvant Therapy-Real World Study
ConditionRectal Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Friendship Hospital
About this trial
This study aims to utilise a real-world data platform to integrate multi-omics data-including radiomics, gut microbiota, pathological quality control and liquid biopsy-to construct a multidimensional predictive model for the efficacy of rectal cancer treatment following neoadjuvant therapy. By integrating multimodal data, the study aims to accurately assess the efficacy of neoadjuvant therapy and identify patients suitable for a 'watch-and-wait' strategy, thereby achieving tumour control and preserving organ function without the need for surgery. Furthermore, it seeks to provide scientific evidence for the efficacy of the 'watch-and-wait' strategy and the selection of optimal timing for surgery, whilst validating the model's effectiveness and assessing its clinical feasibility through prospective clinical trials.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient is informed and has provided written informed consent;
Clinical stage II/III locally advanced rectal cancer (LARC): cT1-4aN0-2M0;
The distal edge of the tumor is ≤ 10 cm from the anal verge (measured by MRI);
No distant metastasis;
Disqualifiers
Presence of distant organ metastasis;
Multiple primary colorectal cancers;
History of prior malignancy (except completely cured carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma of the skin).
Trial population
Patients with rectal cancer undergoing neoadjuvant therapy.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
This study is a multicenter, real-world, non-interventional study.
Other interventionnon-interventional study
Treatment groups
869 Participants
are divided into 1 treatment groupGroup A: Neoadjuvant Therapy Cohort for Rectal Cancer1 intervention
Trial outcomes
Primary outcomes
1
To compare the complete response rates across different treatments.
Compare the complete response rates (including pathological complete response \[pCR\] and clinical complete response \[cCR\]) between a neoadjuvant regimen combining chemoradiotherapy with immunotherapy and the traditional neoadjuvant chemoradiotherapy regimen, in patients with locally advanced rectal cancer.
Time frame
Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)Secondary outcomes
1
Safety profile
Adverse Events (AEs): Type, incidence, severity, and relationship to the study treatment. Severity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI-CTCAE v5.0).
Time frame
20 weeks after the first radiotherapy session2
Therapy Tolerability
The proportions of patients with dose interruption, dose reduction, and treatment discontinuation during the neoadjuvant treatment period, all due to treatment-related toxicity.
Time frame
20 weeks after the first radiotherapy session3
Disease-Free Survival (DFS)
Disease-Free Survival (DFS) is a key endpoint (a measure of outcome) used primarily in oncology clinical trials, especially for evaluating adjuvant or curative treatments.
Time frame
within 5 years after completion of neoadjuvant therapyOther outcomes
1
Overall Survival (OS)
Overall Survival (OS) is the primary and most objective endpoint in oncology clinical trials. It measures the time from a defined starting point (e.g., date of diagnosis, randomization in a trial, or start of treatment) until death from any cause.
Time frame
within 5 years after completion of neoadjuvant therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov