Back to resultsThe Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSS Locally Advanced Rectal Cancer
Primary Purpose
Locally Advanced Rectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PD-1 antibody
Capecitabine
Irinotecan
Neoadjuvant Radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Rectal Cancer
Eligibility Criteria
Inclusion Criteria:
- pathological confirmed adenocarcinoma
- clinical stage T3-4 and/or N+
- the distance from anal verge less than 12 cm
- without distance metastases
- age 18-70 years old, female and male
- KPS >=70
- UGT1A1*28 6/6 or 6/7
- the MSI status is MSS or p-MMR
- without previous anti-cancer therapy or immunotherapy
- with good compliance
- signed the inform consent
Exclusion Criteria:
- pregnancy or breast-feeding women
- history of other malignancies within 5 years
- serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
- immunodeficiency disease or long-term using of immunosuppressive agents
- 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
- DPD deficiency
- UGT1A1*28 7/7
- the MSI status is MSI-H or d-MMR
- allergic to any component of the therapy
Sites / Locations
- Zhen Zhang
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Arm
Arm Description
A total of 50 MSS LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX.
Outcomes
Primary Outcome Measures
Pathologic Complete Response Rate
Pathologic Complete Response Rate
Secondary Outcome Measures
Disease free survival
3 year disease free survival rate
Local recurrence free survival
3 year local recurrence free survival rate
Overall survival
3 year overall survival rate
Adverse effects
Chemoradiation-related or immunotherapy-related adverse events
Surgical complications
Surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
Performance Status (Zubrod-ECOG-WHO method), range 0-5. The higher scores mean a worse quality of life.
Quality of life will be evaluated
Karnofsky Performance Status, range 0-100. The higher scores mean a better quality of life.
Quality of life will be evaluated
Quality of Life Scale, range 0-60. It evaluates the quality of life from 12 aspects, including appetite, mental status, sleep quality, fatigue, etc. The higher scores mean a better quality of life.
Quality of life will be evaluated
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04411537
Brief Title
The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSS Locally Advanced Rectal Cancer
Official Title
A Phase II Trial of Immunotherapy Combined With Neoadjuvant Chemoradiotherapy in Microsatellite Stable Locally Advanced Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stable (MSS) locally advanced rectal cancer (LARC). A total of 50 MSS LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX. The tumor response grade, adverse effects and long-term prognosis will be analyzed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Rectal Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
A total of 50 MSS LARC patients will receive 2 cycles of PD-1 antibody, followed by capecitabine plus irinotecan radiosensitized neoadjuvant chemoradiotherapy, and another 3 cycles of PD-1 antibody, finally received the total mesorectal excision (TME) and 6 cycles of adjuvant chemotherapy of XELOX.
Intervention Type
Drug
Intervention Name(s)
PD-1 antibody
Intervention Description
Before neo-CRT: 2 cycles of PD-1 antibody, 240mg d1 q2w. After neo-CRT: 3 cycles of PD-1 antibody, 240mg d1 q2w.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda
Intervention Description
During neo-CRT: 625mg/m2 bid Monday-Friday per week
Intervention Type
Drug
Intervention Name(s)
Irinotecan
Intervention Description
During neo-CRT: 80mg/m2 qw (UGT1A1*28 6/6) or 65mg/m2 qw (UGT1A1*28 6/7)
Intervention Type
Radiation
Intervention Name(s)
Neoadjuvant Radiotherapy
Intervention Description
IMRT DT: 50Gy/25Fx
Primary Outcome Measure Information:
Title
Pathologic Complete Response Rate
Description
Pathologic Complete Response Rate
Time Frame
The pathologic complete response rate was evaluated after surgery, which was scheduled 7-8 weeks after the end of chemoradiotherapy
Secondary Outcome Measure Information:
Title
Disease free survival
Description
3 year disease free survival rate
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.
Title
Local recurrence free survival
Description
3 year local recurrence free survival rate
Time Frame
From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.
Title
Overall survival
Description
3 year overall survival rate
Time Frame
From date of randomization until the date of death from any cause, assessed up to 36 months.
Title
Adverse effects
Description
Chemoradiation-related or immunotherapy-related adverse events
Time Frame
From date of randomization until the date of death from any cause, assessed up to 5 years
Title
Surgical complications
Description
Surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
Time Frame
The surgery was scheduled 7-8 weeks after the end of chemoradiotherapy. And the surgical complications were assessed up to 5 years from the surgery.
Title
Performance Status (Zubrod-ECOG-WHO method), range 0-5. The higher scores mean a worse quality of life.
Description
Quality of life will be evaluated
Time Frame
From date of randomization until the date of death from any cause, assessed up to 10 years
Title
Karnofsky Performance Status, range 0-100. The higher scores mean a better quality of life.
Description
Quality of life will be evaluated
Time Frame
From date of randomization until the date of death from any cause, assessed up to 10 years
Title
Quality of Life Scale, range 0-60. It evaluates the quality of life from 12 aspects, including appetite, mental status, sleep quality, fatigue, etc. The higher scores mean a better quality of life.
Description
Quality of life will be evaluated
Time Frame
From date of randomization until the date of death from any cause, assessed up to 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pathological confirmed adenocarcinoma
clinical stage T3-4 and/or N+
the distance from anal verge less than 12 cm
without distance metastases
age 18-70 years old, female and male
KPS >=70
UGT1A1*28 6/6 or 6/7
the MSI status is MSS or p-MMR
without previous anti-cancer therapy or immunotherapy
with good compliance
signed the inform consent
Exclusion Criteria:
pregnancy or breast-feeding women
history of other malignancies within 5 years
serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
immunodeficiency disease or long-term using of immunosuppressive agents
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
DPD deficiency
UGT1A1*28 7/7
the MSI status is MSI-H or d-MMR
allergic to any component of the therapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhen zhang, M.D, PH.D
Phone
18801735029
Ext
18801735029
Email
zhen_zhang@fudan.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zhen zhang, M.D, PH.D
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhen Zhang
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhen Zhang, M.D, PH.D
Phone
18801735029
Ext
18801735029
Email
zhen_zhang@fudan.edu.cn
12. IPD Sharing Statement
Learn more about this trial
The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSS Locally Advanced Rectal Cancer
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