Rectal Cancer Neoadjuvant Therapy-Real World Study

NCT07566559 | Recruiting DMC

• 1 other identifier: MR-11-26-025202
• Study Type: observational
• Target: 869
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectal Cancer

Keywords

Rectal cancer; Real world study; Neoadjuvant Therapy

Outcome Measures

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.

  Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)

Secondary Outcomes (3)

• Safety profile

  20 weeks after the first radiotherapy session

• Therapy Tolerability

  20 weeks after the first radiotherapy session

• Disease-Free Survival (DFS)

  within 5 years after completion of neoadjuvant therapy

Other Outcomes (1)

• Overall Survival (OS)

  within 5 years after completion of neoadjuvant therapy

Study Arms (1)

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).

Other: This study is a multicenter, real-world, non-interventional study.

Interventions

This study is a multicenter, real-world, non-interventional study. OTHER

non-interventional study

Neoadjuvant Therapy Cohort for Rectal Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with rectal cancer undergoing neoadjuvant therapy.

You may qualify if:

• 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。

You may not qualify if:

• 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).

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

hongwei Yao, Professor, Doctoral Degree

CONTACT

63139203; yaohongwei@ccmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant, Professor

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: May 5, 2026
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CN (1)