Clinical trial NCT06455124: Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)
Official title: Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: early rectal cancer
high risk
local excision
radiation
PD-1 inhibitor
chemotherapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 3y LRFS
timeFrame: From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
Secondary outcomes:
measure: 3y DFS
timeFrame: 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.
measure: 3y OS
timeFrame: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
measure: Grade 3-4 adverse effects rate
timeFrame: From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
References: