Clinical trial · Observational
Rectal Cancer Neoadjuvant Therapy-Real World Study
Establishing a Strategy for Selecting Watchful Waiting and Determining the Optimal Timing for Surgery Following Neoadjuvant Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| This study is a multicenter, real-world, non-interventional study. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Neoadjuvant Therapy Cohort for Rectal Cancer
- description
- 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).
- interventionNames
- Other: This study is a multicenter, real-world, non-interventional study.
Primary outcomes (1)
- measure
- To compare the complete response rates across different treatments.
- timeFrame
- Post-neoadjuvant Therapy Efficacy Assessment Time Point (within 8-12 weeks after radiotherapy completion)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The patient is informed and has provided written informed consent; * Rectal adenocarcinoma confirmed by colonoscopic biopsy and pathology, meeting the following criteria: 1. Clinical stage II/III locally advanced rectal cancer (LARC): cT1-4aN0-2M0; 2. The distal edge of the tumor is ≤ 10 cm from the anal verge (measured by MRI); 3. No distant metastasis; 4. Scheduled to receive neoadjuvant therapy; * Age ≥ 18 years, male or female。 Exclusion Criteria: * 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).
References
Publications (0)
Data not yet available