Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)

Rectal Cancer Clinical Trial

Official title:

Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06455124
• Other study ID #: FDRT-2024-31-3584
• Status: Recruiting
• Phase: Phase 2
• Start date: May 8, 2024
• Est. completion date: December 30, 2029

Study information

• Verified date: June 2024
• Source: Fudan University
• Contact: Zhen Zhang
• Phone: 021-64175590
• Email: zhen_zhang[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2029
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Radiation:
• Radiation
Shor-course radiotherapy: 25Gy/5Fx

Drug:
• PD-1 antibody
PD-1 antibody (Toripalimab): 240mg d1 q3w
• Capecitabine
Capecitabine: 1000mg/m2 d1-14 q3w
• Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3y LRFS	Rate of 3 year local recurrence free survival rate	From date of initiation of treatment until the date of first documented pelvic failure, assessed up to 36 months.
Secondary	3y DFS	Rate of 3 year disease free survival	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.
Secondary	3y OS	Rate of 3 year overall survival	From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.
Secondary	Grade 3-4 adverse effects rate	Rate of chemotherapy, radiotherapy and immunotherapy related adverse events	From date of initiation of treatment until the date of death from any cause, assessed up to 36 months.