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The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSI-H Locally Advanced Rectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04411524
Recruitment Status : Unknown
Verified May 2020 by Zhen Zhang, Fudan University.
Recruitment status was:  Not yet recruiting
First Posted : June 2, 2020
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Zhen Zhang, Fudan University

Study Description
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Brief Summary:
The study evaluates the addition of immunotherapy of PD-1 antibody in neoadjuvant chemoradiotherapy in microsatellite stability-high (MSI-H) locally advanced rectal cancer (LARC). 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. The tumor response grade, adverse effects and long-term prognosis will be analyzed.

Condition or disease Intervention/treatment Phase
Locally Advanced Rectal Cancer Drug: PD-1 antibody Drug: Capecitabine Drug: Irinotecan Radiation: Neoadjuvant Radiotherapy Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Immunotherapy Combined With Neoadjuvant Chemoradiotherapy in Microsatellite Instability-High Locally Advanced Rectal Cancer
Estimated Study Start Date : July 1, 2020
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: PD-1 antibody
Before neo-CRT: 2 cycles of PD-1 antibody After neo-CRT: 3 cycles of PD-1 antibody

Drug: Capecitabine
During neo-CRT: 625mg/m2 bid Monday-Friday per week
Other Name: Xeloda

Drug: Irinotecan
During neo-CRT: 80mg/m2 qw (UGT1A1*28 6/6) or 65mg/m2 qw (UGT1A1*28 6/7)

Radiation: Neoadjuvant Radiotherapy
IMRT DT: 50Gy/25Fx


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]
    Pathologic Complete Response Rate


Secondary Outcome Measures :
  1. Disease free survival [ 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. ]
    3 year disease free survival rate

  2. Local recurrence free survival [ Time Frame: From date of randomization until the date of first documented pelvic failure, assessed up to 36 months. ]
    3 year local recurrence free survival rate

  3. Overall survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 36 months. ]
    3 year overall survival rate

  4. Adverse effects [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 5 years ]
    Chemoradiation-related or immunotherapy-related adverse events

  5. Surgical complications [ 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. ]
    Surgical complications, such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.

  6. Performance Status (Zubrod-ECOG-WHO method), range 0-5. The higher scores mean a worse quality of life. [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 10 years ]
    Quality of life will be evaluated

  7. Karnofsky Performance Status, range 0-100. The higher scores mean a better quality of life. [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 10 years ]
    Quality of life will be evaluated

  8. 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. [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 10 years ]
    Quality of life will be evaluated


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. pathological confirmed adenocarcinoma
  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:

  1. pregnancy or breast-feeding women
  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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04411524


Contacts
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Contact: Zhen Zhang, M.D, PH.D 18801735029 ext 18801735029 zhen_zhang@fudan.edu.cn

Locations
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China, Shanghai
Zhen Zhang
Shanghai, Shanghai, China, 200032
Contact: Zhen Zhang, M.D, PH.D    18801735029 ext 18801735029    zhen_zhang@fudan.edu.cn   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Zhen Zhang, M.D, PH.D Fudan University
More Information
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Responsible Party: Zhen Zhang, Professor, Fudan University
ClinicalTrials.gov Identifier: NCT04411524    
Other Study ID Numbers: FDRT-2019-104-1734
First Posted: June 2, 2020    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
 Irinotecan
Antibodies
Immunologic Factors
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors