The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSI-H Locally Advanced Rectal Cancer
NCT ID: NCT04411524
Last Updated: 2020-06-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
50 participants
INTERVENTIONAL
2020-07-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment Arm
A total of 50 MSI-H 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.
PD-1 antibody
Before neo-CRT: 2 cycles of PD-1 antibody After neo-CRT: 3 cycles of PD-1 antibody
Capecitabine
During neo-CRT: 625mg/m2 bid Monday-Friday per week
Irinotecan
During neo-CRT: 80mg/m2 qw (UGT1A1\*28 6/6) or 65mg/m2 qw (UGT1A1\*28 6/7)
Neoadjuvant Radiotherapy
IMRT DT: 50Gy/25Fx
Interventions
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PD-1 antibody
Before neo-CRT: 2 cycles of PD-1 antibody After neo-CRT: 3 cycles of PD-1 antibody
Capecitabine
During neo-CRT: 625mg/m2 bid Monday-Friday per week
Irinotecan
During neo-CRT: 80mg/m2 qw (UGT1A1\*28 6/6) or 65mg/m2 qw (UGT1A1\*28 6/7)
Neoadjuvant Radiotherapy
IMRT DT: 50Gy/25Fx
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. clinical stage T3-4 and/or N+
3. the distance from anal verge less than 12 cm
4. without distance metastases
5. age 18-70 years old, female and male
6. KPS \>=70
7. UGT1A1\*28 6/6 or 6/7
8. the MSI status is MSI-H or d-MMR
9. without previous anti-cancer therapy or immunotherapy
10. with good compliance
11. signed the inform consent
Exclusion Criteria
2. history of other malignancies within 5 years
3. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
4. immunodeficiency disease or long-term using of immunosuppressive agents
5. 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
6. DPD deficiency
7. UGT1A1\*28 7/7
8. the MSI status is MSS or p-MMR
9. allergic to any component of the therapy
15 Years
70 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhen Zhang
Professor
Principal Investigators
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Zhen Zhang, M.D, PH.D
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Zhen Zhang
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FDRT-2019-104-1734
Identifier Type: -
Identifier Source: org_study_id
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