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Establishing a Strategy for Selecting Watchful Waiting and Determining the Optimal Timing for Surgery Following Neoadjuvant Therapy

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• The patient is informed and has provided written informed consent;

• Rectal adenocarcinoma confirmed by colonoscopic biopsy and pathology, meeting the following criteria:

‣ 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;

⁃ Scheduled to receive neoadjuvant therapy;

• Age ≥ 18 years, male or female。

Locations
Other Locations
China
Beijing Friendship Hospital
RECRUITING
Beijing
Contact Information
Primary
hongwei Yao, Professor, Doctoral Degree
yaohongwei@ccmu.edu.cn
63139203
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 869
Treatments
Neoadjuvant Therapy Cohort for Rectal Cancer
This study is a multicentre, real-world evidence (RWE) study designed to evaluate clinical treatment regimens that offer greater benefits to patients. It will provide evidence-based guidance for clinicians in China regarding the selection of comprehensive treatment regimens for patients with advanced rectal cancer, thereby further refining and optimising clinical practice guidelines for the diagnosis and treatment of rectal cancer; it will also explore new treatment strategies for patients with locally advanced rectal cancer in the era of immunotherapy. Study design: A combination of prospective observational and retrospective cohort studies. The primary endpoint is the complete response rate (pathological complete response and clinical complete response).
Related Therapeutic Areas
Sponsors
Leads: Beijing Friendship Hospital

This content was sourced from clinicaltrials.gov