NCT07260526 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
| NCT ID | NCT07260526 |
| Status | Recruiting |
| Phase | — |
| Sponsor | West China Hospital |
| Condition | Rectal Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-10-01 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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: 1. The lower edge of the tumor is ≤5 cm from the anal verge as measured by digital rectal examination or MRI; 2. Clinical stage cT1-3abN0-1M0 (for cT1N0, patients suitable for endoscopic resection are excluded); 3. MRF (-) (\>1 mm), EMVI (±); 4. Negative lateral lymph nodes and \<7 mm in size; 5. Maximum tumor length ≤5 cm; 6. 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07260526 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07260526 currently recruiting?
Yes, NCT07260526 is actively recruiting participants. Contact the research team at wangziqiang@scu.edu.cn for enrollment information.
Where is the NCT07260526 trial being conducted?
This trial is being conducted at Chengdu, China.
Who is sponsoring the NCT07260526 clinical trial?
NCT07260526 is sponsored by West China Hospital. The trial plans to enroll 60 participants.
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