- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04411537
The Combination of Immunotherapy and Neoadjuvant Chemoradiotherapy in MSS Locally Advanced Rectal Cancer
June 1, 2020 updated by: Zhen Zhang, Fudan University
A Phase II Trial of Immunotherapy Combined With Neoadjuvant Chemoradiotherapy in Microsatellite Stable Locally Advanced Rectal Cancer
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Zhen Zhang
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treatment Arm
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.
|
Before neo-CRT: 2 cycles of PD-1 antibody, 240mg d1 q2w.
After neo-CRT: 3 cycles of PD-1 antibody, 240mg d1 q2w.
During neo-CRT: 625mg/m2 bid Monday-Friday per week
Other Names:
During neo-CRT: 80mg/m2 qw (UGT1A1*28 6/6) or 65mg/m2 qw (UGT1A1*28 6/7)
IMRT DT: 50Gy/25Fx
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
The pathologic complete response rate was evaluated after surgery, which was scheduled 7-8 weeks after the end of chemoradiotherapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
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
|
From date of randomization until the date of first documented pelvic failure, assessed up to 36 months.
|
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
|
From date of randomization until the date of death from any cause, assessed up to 36 months.
|
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
|
From date of randomization until the date of death from any cause, assessed up to 5 years
|
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.
|
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.
|
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
|
From date of randomization until the date of death from any cause, assessed up to 10 years
|
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
|
From date of randomization until the date of death from any cause, assessed up to 10 years
|
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
|
From date of randomization until the date of death from any cause, assessed up to 10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
July 1, 2020
Primary Completion (ANTICIPATED)
April 30, 2022
Study Completion (ANTICIPATED)
December 31, 2022
Study Registration Dates
First Submitted
May 10, 2020
First Submitted That Met QC Criteria
June 1, 2020
First Posted (ACTUAL)
June 2, 2020
Study Record Updates
Last Update Posted (ACTUAL)
June 2, 2020
Last Update Submitted That Met QC Criteria
June 1, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunologic Factors
- Topoisomerase Inhibitors
- Topoisomerase I Inhibitors
- Antibodies
- Capecitabine
- Irinotecan
Other Study ID Numbers
- FDRT-2019-97-1731
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Locally Advanced Rectal Cancer
-
Fondazione Policlinico Universitario Agostino Gemelli...Viewray Inc.UnknownLocally Advanced Rectal Cancer | Pathological Complete Response | Neoadjuvant ChemoradiotherapyItaly
-
University Hospital Southampton NHS Foundation...Cancer Research UK; IntraOp Medical Corporation; PLANETS Cancer CharityRecruitingLocally Advanced Rectal Cancer | Locally Recurrent Rectal CancerUnited Kingdom
-
St Vincent's University Hospital, IrelandRecruitingLocally Advanced Rectal Cancer | Pelvic Exenteration | Advanced Pelvic MalignancyIreland
-
Beijing Friendship HospitalChanghai Hospital; Peking Union Medical College Hospital; Peking University Cancer...Not yet recruitingLocally Advanced Rectal CancerChina
-
Sun Yat-sen UniversityAkeso; Haplox Biotechnology Co., Ltd.RecruitingLocally Advanced Rectal CancerChina
-
Peking Union Medical College HospitalNot yet recruitingLocally Advanced Rectal Cancer
-
Beijing Friendship HospitalPeking University First Hospital; Peking University People's Hospital; Peking... and other collaboratorsRecruitingLocally Advanced Rectal CancerChina
-
Zhejiang Cancer HospitalRecruiting
-
Fundación para el Fomento de la Investigación Sanitaria...Hospital General Universitario ElcheRecruiting
-
Gruppo Oncologico del Nord-OvestActive, not recruitingLocally Advanced Rectal CancerItaly
Clinical Trials on PD-1 antibody
-
The First Affiliated Hospital with Nanjing Medical...Recruiting
-
Beijing Tongren HospitalNot yet recruitingExtranodal NK/T-cell Lymphoma, Nasal Type
-
Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Nanfang Hospital of Southern... and other collaboratorsRecruitingNasopharyngeal Carcinoma | Surgery | PD-1China
-
Tianjin Medical University Cancer Institute and...Jiangsu HengRui Medicine Co., Ltd.Completed
-
Nanjing Leads Biolabs Co.,LtdRecruitingAdvanced Malignant TumorsChina
-
Eye & ENT Hospital of Fudan UniversityNot yet recruitingNasopharyngeal Carcinoma
-
Henlix, IncUnknown
-
Sun Yat-sen UniversityRecruitingColorectal Cancer Metastatic | MSSChina
-
Zhujiang HospitalNot yet recruitingHepatocellular Carcinoma Non-resectable
-
Virginia Commonwealth UniversityNational Cancer Institute (NCI)CompletedSolid TumorUnited States