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Response-adapted total neoadjuvant therapy guided by induction chemotherapy in early- and intermediate-risk low rectal cancer: an observational study for watch-and-wait strategy

Response-adapted total neoadjuvant therapy guided by induction chemotherapy in early- and intermediate-risk low rectal cancer: an observational study for watch-and-wait strategy

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113437
Enrollment
Unknown
Registered
2025-11-28
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

Full neoadjuvant therapy in the observation group of low - and medium-risk low rectal cancer:None

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age: 18 -80 years old; Gender is not limited. 2. Rectal adenocarcinoma confirmed by pathology, and immunohistochemical and/or genetic testing as pMMR/MSS; 3. The tumor evaluated by thoracoabdominal CT, rectal color Doppler ultrasound and MRI has the following characteristics: The distance from the lower edge of the tumor to the anal edge measured by digital rectal examination or MRI is 1mm), EMVI (+/-); The lateral lymph nodes are negative and less than 7mm. The long diameter of the tumor is less than or equal to 5cm. The tumor circumference is less than or equal to 2/3. 4. MRI assessment was effective after two or more cycles of XELOX regimen induction chemotherapy (tumor long diameter) A reduction of =30% compared to before treatment. 5. Subsequently complete TNT treatment (including long-term chemoradiotherapy and consolidation chemotherapy, with 25 to 28 sessions of radiotherapy and 6 to 8 cycles of chemotherapy). 6. (Prospective Part) Sign the informed consent form for this observational study.

Exclusion criteria

Exclusion criteria: 1.History of or concurrent other malignancies (except for cured basal cell carcinoma of the skin or carcinoma in situ of the cervix); 2.Incomplete clinical data precluding effective evaluation; 3.(For the prospective cohort) Refusal to provide written informed consent;

Design outcomes

Primary

MeasureTime frame
Organ preservation rate;

Secondary

MeasureTime frame
Clinical complete response;Local recurrence rate;Metastasis-free survival rate;Local regrowth rate;Overall survival rate;pCR rate;

Countries

China

Contacts

Public ContactZiqiang Wang

West China Hospital of Sichuan University

wangziqiang@scu.edu.cn+86 28 85422480

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026