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Trial Title:
Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced，High-Risk，MSS Rectal Cancer
NCT ID:
NCT05877573
Condition:
Locally Advanced
High-Risk
Rectal Cancer
MSS
Conditions: Official terms:
Rectal Neoplasms
Capecitabine
Oxaliplatin
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Toripalimab 240mg,d1,q3w
Arm group label:
short-course radiotherapy plus chemotherapy and immunotherapy
Intervention type:
Radiation
Intervention name:
short-term radiotherapy
Description:
25Gy/5Fx
Arm group label:
short-course radiotherapy plus chemotherapy and immunotherapy
Other name:
shor-course radiotherapy
Intervention type:
Drug
Intervention name:
Oxaliplatin
Description:
135mg/m2 d1 q3w
Arm group label:
short-course radiotherapy plus chemotherapy and immunotherapy
Intervention type:
Drug
Intervention name:
Capecitabine
Description:
1200mg/m2 d1-14 q3w
Arm group label:
short-course radiotherapy plus chemotherapy and immunotherapy
Summary:
This is a single arm, open-label, prospective clinical trial to evaluate the combination
of neoadjuvant short-course radiotherapy and toripalimab (PD-1 antibody) for locally
advanced rectal cancer (LARC) patients with high risk factors. A total of 53patients will
be enrolled in this trial to receive 5*5Gy short-course radiotherapy, followed by 4
cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery
and another 2 cycles of CAPOX chemotherapy. The primary end point is the rate of
pathological complete response (pCR). The long-term prognosis and adverse effects will
also be evaluated and analyzed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Age 18-75 years old, female and male;
- Pathological confirmed MSS or pMMR rectal adenocarcinoma;
- Clinical stage T3-4 (AJCC 8th) and at least with one high risk factor（CRM+ or EMVI+
or lateral lymph nodes+）;
- No previous chemotherapy, radiotherapy, immunotherapy or other anti-tumor treatment;
- Adequate organ function defined at baseline as:
ANC ≥1.5××109/L，PLt ≥100×109 /L，Hb ≥90 g/L，15×109 /L≥WBC≥4×109 /L; TBIL ≤1.5×ULN, ALT
≤1.5ULN, AST ≤1.5ULN, BUN and Cr ≤1.5×ULN or Ccr
- 60ml/min (Cockcroft-Gault formula);INR ≤1.5×ULN or PT ≤1.5×ULN (when patient didn't
accept anticoagulant therapy);
- Women of childbearing age must have taken reliable contraceptive measures or
have a pregnancy test (serum or urine) within 7 days prior to enrollment and
the results are negative;
Exclusion Criteria:
- Pathological confirmed rectal squamous cell carcinoma;
- History of other uncured malignancies within 5 years;
- Allergic to any component of chemotherapy or immunotherapy;
- History of any active, known, or suspected autoimmune disease, including but not
limited to myasthenia gravis,Myositis, autoimmune hepatitis, systemic lupus
erythematosus, rheumatoid arthritis,Inflammatory bowel disease, vascular thrombosis
associated with antiphospholipid syndrome, Wegener granulation Swollen disease,
Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or
Glomerulonephritis.
- With congenital or acquired immunodeficiency (such as those with HIV infection),
active hepatitis B or hepatitis C;
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanfang Hospital Southern Medical University
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yaowei Zhang, MD
Phone:
86-20-17819575181
Email:
weiyaozhang2@163.com
Start date:
July 1, 2023
Completion date:
August 1, 2026
Lead sponsor:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Collaborator:
Agency:
Shanghai Junshi Bioscience Co., Ltd.
Agency class:
Other
Source:
Nanfang Hospital, Southern Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05877573
