Response-adapted Total Neoadjuvant Therapy Guided by Induction Chemotherapy in Early- and Intermediate-risk Low Rectal Cancer for Implementation of a Watch-and-wait Strategy

NCT07260526 | Recruiting DMC

• 1 other identifier: WCH20250924
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the feasibility of an organ-preserving "watch-and-wait" strategy in patients with mid-to-low rectal cancer who achieve a good response after total neoadjuvant therapy (TNT). By retrospectively and prospectively analyzing patients who complete TNT following effective induction chemotherapy, the study aims to assess organ preservation rates and evaluate whether non-surgical management can provide comparable oncologic outcomes to radical surgery while improving functional recovery and quality of life.

Conditions

Rectal Cancer

Keywords

rectal cancer; total neoadjuvant therapy; watch-and-wait strategy

Outcome Measures

Primary Outcomes (1)

• 1-year organ preservation rate

  defined as the proportion of the following two groups among the total study population：① Patients evaluated as having a clinical complete response (cCR) or near cCR at 8 weeks after radiotherapy who choose a watch-and-wait strategy and maintain cCR for 1 year; ② Patients evaluated as having a cCR or near cCR at 8 weeks after radiotherapy who ultimately undergo local excision and remain recurrence-free for 1 year without requiring salvage surgery.

  1 year after completion of neoadjuvant radiotherapy

Secondary Outcomes (2)

• 1-year metastasis-free survival

  1 year after total neoadjuvant therapy

• 1-year overall survival

  1 year after total neoadjuvant therapy

Study Arms (1)

ITNT group

Patients who achieve a good response after total neoadjuvant therapy and receive organ preservation strategy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with mid-to-low rectal cancer who respond well to induction chemotherapy and subsequently complete total neoadjuvant therapy in order to observe the organ preservation rate after total neoadjuvant therapy.

You may qualify if:

• Age: 18-80 years; no restriction on sex.
• Histologically confirmed rectal adenocarcinoma with immunohistochemistry and/or genetic testing showing pMMR/MSS status.
• Tumor characteristics assessed by chest-abdominal CT, rectal ultrasound, and MRI meeting all of the following criteria:
• The lower edge of the tumor is ≤5 cm from the anal verge as measured by digital rectal examination or MRI;
• Clinical stage cT1-3abN0-1M0 (for cT1N0, patients suitable for endoscopic resection are excluded);
• MRF (-) (\>1 mm), EMVI (±);
• Negative lateral lymph nodes and \<7 mm in size;
• Maximum tumor length ≤5 cm;
• Tumor circumference involvement ≤2/3.
• After receiving at least two cycles of induction chemotherapy with the XELOX regimen, MRI assessment shows treatment response (tumor length reduced by ≥30% compared with baseline).
• Completion of total neoadjuvant therapy (TNT), including long-course chemoradiotherapy and consolidation chemotherapy (radiotherapy: 25-28 fractions; chemotherapy: 6-8 cycles).
• (For the prospective cohort) Provision of written informed consent for participation in this observational study.

You may not qualify if:

• Patients with a history of, or concurrent, other malignant tumors (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix);
• Patients with severely incomplete clinical data that preclude effective evaluation;
• (For the prospective cohort) Patients who refuse to provide written informed consent.

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China hospital, Sichuan University

Chengdu, Sichuan, 610041, 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

Ziqiang Wang, M.D.

CONTACT

+86 18980602028; wangziqiang@scu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Colorectal Surgery, Clinical Professor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 3, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

CN (1)