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Trial Title:
Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)
NCT ID:
NCT06455124
Condition:
Rectal Cancer
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Oxaliplatin
Antibodies
Conditions: Keywords:
early rectal cancer
high risk
local excision
radiation
PD-1 inhibitor
chemotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiation
Description:
Shor-course radiotherapy: 25Gy/5Fx
Arm group label:
Arm1
Intervention type:
Drug
Intervention name:
PD-1 antibody
Description:
PD-1 antibody (Toripalimab): 240mg d1 q3w
Arm group label:
Arm1
Other name:
Toripalimab
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
Capecitabine: 1000mg/m2 d1-14 q3w
Arm group label:
Arm1
Other name:
Xeloda
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
Oxaliplatin: 130mg/m2 d1 q3w
Arm group label:
Arm1
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhen Zhang, MD, PHD
Phone:
021-64175590
Email:
zhen_zhang@fudan.edu.cn
Start date:
May 8, 2024
Completion date:
December 30, 2029
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06455124
