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Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced,High-Risk,MSS Rectal Cancer

Primary Purpose

Locally Advanced, High-Risk, Rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Toripalimab
short-term radiotherapy
Oxaliplatin
Capecitabine
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Nanfang Hospital Southern Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

short-course radiotherapy plus chemotherapy and immunotherapy

Arm Description

A total of 53 patients receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TME surgery and another 2 cycles of CAPOX chemotherapy.

Outcomes

Primary Outcome Measures

pCR rate
Pathologic complete response rate

Secondary Outcome Measures

3-year ORR
3-year objective response rate
3-year DCR
3-year disease control rate
3-year OS
3-year overall survival rate
AE
adverse event
SAE
Serious Adverse Event

Full Information

First Posted
May 17, 2023
Last Updated
July 2, 2023
Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Shanghai Junshi Bioscience Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05877573
Brief Title
Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced,High-Risk,MSS Rectal Cancer
Official Title
Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced,High-Risk,MSS Rectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
August 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University
Collaborators
Shanghai Junshi Bioscience Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced, High-Risk, Rectal Cancer, MSS

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
short-course radiotherapy plus chemotherapy and immunotherapy
Arm Type
Experimental
Arm Description
A total of 53 patients receive 5*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody, finally receive the TME surgery and another 2 cycles of CAPOX chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Toripalimab
Intervention Description
Toripalimab 240mg,d1,q3w
Intervention Type
Radiation
Intervention Name(s)
short-term radiotherapy
Other Intervention Name(s)
shor-course radiotherapy
Intervention Description
25Gy/5Fx
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
135mg/m2 d1 q3w
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
1200mg/m2 d1-14 q3w
Primary Outcome Measure Information:
Title
pCR rate
Description
Pathologic complete response rate
Time Frame
The TME surgery will be recommended after the neoadjuvant therapy. The pCR rate is evaluated after surgery. Assessed up to 6 months
Secondary Outcome Measure Information:
Title
3-year ORR
Description
3-year objective response rate
Time Frame
Assessed up to 3 years
Title
3-year DCR
Description
3-year disease control rate
Time Frame
Assessed up to 3 years
Title
3-year OS
Description
3-year overall survival rate
Time Frame
Assessed up to 3 years
Title
AE
Description
adverse event
Time Frame
Assessed up to 3 years
Title
SAE
Description
Serious Adverse Event
Time Frame
Assessed up to 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Ding, MD
Phone
86-20-13729852980
Email
dingyi197980@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yaowei Zhang, MD
Phone
86-20-17819575181
Email
weiyaozhang2@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dehua Wu, MD
Organizational Affiliation
Nanfang Hospital, Southern Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanfang Hospital Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaowei Zhang, MD
Phone
86-20-17819575181
Email
weiyaozhang2@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Toripalimab Combined With Neoadjuvant Chemoradiotherapy as First-line Treatment for Locally Advanced,High-Risk,MSS Rectal Cancer

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