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Observation on the short-term efficacy of neoadjuvant long-course chemoradiotherapy-consolidation treatment model combined with tislelizab in advanced rectal cancer

Observation of the short-term efficacy of neoadjuvant chemoradiotherapy followed by consolidation treatment with tislelizumab in locally rectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500098692
Enrollment
Unknown
Registered
2025-03-12
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-03-17

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

Conditions

pMMR locally advanced rectal cancer

Interventions

experimental group:Sequential CAPEOX regimen combined with trastuzumab after full course neoadjuvant long-term radiotherapy and chemotherapy
control group:Standard full course neoadjuvant long-term radiotherapy and chemotherapy

Sponsors

Gansu Provincial Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Ages between 18 and 70 years old; 2. Histopathologically confirmed rectal adenocarcinoma non-dMMR type; 3. Patients with a tumor lower edge distance from the anal verge 70 points; 6. No severe complications and obvious contrainations to radiotherapy, chemotherapy, and surgery; 7. No second primary tumor.

Exclusion criteria

Exclusion criteria: 1. Advanced rectal cancer confirmed by immunohistochemistry as dMMR/MSI-H; 2. Tumor lower margin 10 cm from the anal verge, low risk of recurrence (EMVI-, MRF-, lateral lymph nodes-, non-cT3-4); 3. Those with distant metastasis, severe comorbidities, and contraindications to radiotherapy, chemotherapy, and surgery; 4. Those with mental and diseases such as depression and mania; 5. Pregnant and lactating women; 6. Those who do not accept observation and are unwilling to be treated; 7.Those who are currently participating in other clinical trials;

Design outcomes

Primary

MeasureTime frame
Clinical complete response (CCR) rate;Pathological complete remission (PCR) rate;

Secondary

MeasureTime frame
Preoperative treatment for death cases;Perioperative mortality cases;Intestinal dysfunction;Anastomotic fistula;intestinal obstruction;Severe bone marrow suppression;Assessment of Quality of Life;

Countries

China

Contacts

Public ContactZhou Xiadong

Gansu Provincial Cancer Hospita

zhouxd1980@163.com+86 136 5931 2905

Outcome results

None listed

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