Rectal Cancer
Conditions
Keywords
early rectal cancer, high risk, local excision, radiation, PD-1 inhibitor, chemotherapy
Brief summary
This is a single arm phase II study to explore the 3y LRFS and safety for high-risk early rectal cancer after local excision with short-course radiotherapy and chemo-immunotherapy.
Detailed description
A total of 60 patients with high-risk pathologic stage pT1 or pT2 cancer after local excision but refused radical surgery will be included. Eligibility criteria include a histological diagnosis of adenocarcinoma located ≤7 cm from the anal verge, pT1 after local excision of the primary rectal cancer, with one of the high-risk features including margin positivity/very close margin (\<1mm) at time of local excision, depth of invasion \>1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor. They will receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody.
Interventions
RADIATIONRadiation
Shor-course radiotherapy: 25Gy/5Fx
DRUGPD-1 antibody
PD-1 antibody (Toripalimab): 240mg d1 q3w
DRUGCapecitabine
Capecitabine: 1000mg/m2 d1-14 q3w
DRUGOxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. age 18-75 years old, female and male 2. pathological confirmed adenocarcinoma 3. the distance from anal verge ≤ 7 cm 4. pT1 after local excision of the primary rectal cancer, with at least one of the high-risk features including margin positivity/very close margin (\<1mm) at time of local excision, depth of invasion \>1 mm or SM3 invasion (submucosal invasion to the lower third of the submucosal level), high grade or poorly differentiated, lymphovascular invasion, perineural invasion, tumour budding, or pT2 tumor. 5. refuse radical surgery 6. without pelvic or distance metastases 7. KPS \>=70 8. with good compliance 9. microsatellite repair status is MSS/pMMR 10. without previous anti-cancer therapy or immunotherapy 11. signed the inform consent
Exclusion criteria
1. pregnancy or breast-feeding women 2. pathological confirmed signet ring cell carcinoma 3. history of other malignancies within 5 years 4. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc. 5. immunodeficiency disease or long-term using of immunosuppressive agents 6. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN 7. DPD deficiency 8. allergic to any component of the therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3y LRFS | From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months. | Rate of 3 year local recurrence free survival rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3y DFS | From date of initiation of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. | Rate of 3 year disease free survival |
| 3y OS | From date of initiation of treatment until the date of death from any cause, assessed up to 36 months. | Rate of 3 year overall survival |
| Grade 3-4 adverse effects rate | From date of initiation of treatment until the date of death from any cause, assessed up to 36 months. | Rate of chemotherapy, radiotherapy and immunotherapy related adverse events |
Countries
China
Contacts
Primary ContactZhen Zhang
Outcome results
None listed