Metastatic colorectal cancer is one of the common malignant tumors and the overall prognosis is poor. The introduction of immune-checkpoint inhibition (ICI) has led to a paradigm shift in the treatment of patients with metastatic cancer. Stereotactic body radiation therapy (SBRT) delivers a large dose of radiation to the tumor target with high precision while sparing irradiation of the surrounding normal tissues. It is suggested that SBRT could be the most appropriate radiotherapy modality to be combined with immunotherapy since it induces the expression of a series of cytokines and new tumour-associated antigens (TAAs) and is more likely to cause intense immune response and exert an abscopal effect than conventional radiotherapy.
Thus, this study is to explore the use of SBRT in combination with ICI in colorectal cancer patients with oligometastasis, in order to get better local and systemic tumor control and improve progress-free survival (PFS).
Condition or disease | Intervention/treatment | Phase |
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Metastatic Colorectal Cancer | Drug: Toripalimab Radiation: Stereotactic Body Radiotherapy | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | All enrolled patients will receive Toripalimab following stereotactic body radiotherapy |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Toripalimab (JS001) Plus Stereotactic Body Radiotherapy in Colorectal Cancer Patients With Oligometastasis |
Actual Study Start Date : | March 1, 2019 |
Estimated Primary Completion Date : | March 1, 2021 |
Estimated Study Completion Date : | September 1, 2021 |
Arm | Intervention/treatment |
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Experimental: SBRT+Toripalimab
Participants received SBRT (BED>80Gy) to oligometastatic lesions and then receive Toripalimab (240mg)/q3w till progression of disease.
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Drug: Toripalimab
Participants receive Toripalimab (240mg)/q3w till progression of disease after SBRT
Radiation: Stereotactic Body Radiotherapy Participants receive SBRT (BED>80Gy) to oligometastatic lesions followed by Toripalimab (240mg)/q3w
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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function, as defined by the following:
Hemoglobin ≥ 100 g/L; White blood cell count (WBC) ≥3.5×109/L , Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelets ≥75×109/L; Serum creatinine ≤ 1.0 x institutional upper limit of normal (ULN) ; Blood Urea Nitrogen(BUN) ≤ 1.0 x institutional (ULN) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 x institutional ULN ALkaline Phosphatase (ALP) ≤ 1.5 x institutional ULN Serum total bilirubin (TBIL) ≤1.5 x institutional ULN Urine protein is negative , Coagulation function is normal
Exclusion Criteria:
Has received systemic therapy within 4 weeks prior to study Day 1 of the trial treatment or who has not recovered from adverse events due to a previously administered agent.
Note: Subjects with ≤ Grade 2 neuropathy or myelosuppression are an exception to this criterion and may qualify for the study.
Contact: Jing Jin, M.D | +86-1087787568 | jingjin1025@163.com | |
Contact: Jianyang Wang, M.D. | +86-1087788122 | pkucell@163.com |
China, Beijing | |
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Recruiting |
Beijing, Beijing, China, 100021 | |
Contact: Wenyang Liu, MD liuwenyang26@163.com | |
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Recruiting |
Beijing, Beijing, China, 100021 | |
Contact: Jianyang Wang, MD +86-13810095191 pkucell@163.com | |
Contact: Jing Jin, MD +86-10-87788122 jingjin1025@163.com | |
China | |
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Recruiting |
Beijing, China, 100021 | |
Contact: Jing Jin, MD +8613601365130 jingjin1025@163.com |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 9, 2019 | ||||||||
First Posted Date ICMJE | April 25, 2019 | ||||||||
Last Update Posted Date | April 25, 2019 | ||||||||
Actual Study Start Date ICMJE | March 1, 2019 | ||||||||
Estimated Primary Completion Date | March 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
1 year Progression-Free-Survival (PFS) [ Time Frame: 1 year ] 1 year PFS
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Phase II Study of Toripalimab Plus Stereotactic Body Radiotherapy in Colorectal Cancer Patients With Oligometastasis | ||||||||
Official Title ICMJE | Phase II Study of Toripalimab (JS001) Plus Stereotactic Body Radiotherapy in Colorectal Cancer Patients With Oligometastasis | ||||||||
Brief Summary |
Metastatic colorectal cancer is one of the common malignant tumors and the overall prognosis is poor. The introduction of immune-checkpoint inhibition (ICI) has led to a paradigm shift in the treatment of patients with metastatic cancer. Stereotactic body radiation therapy (SBRT) delivers a large dose of radiation to the tumor target with high precision while sparing irradiation of the surrounding normal tissues. It is suggested that SBRT could be the most appropriate radiotherapy modality to be combined with immunotherapy since it induces the expression of a series of cytokines and new tumour-associated antigens (TAAs) and is more likely to cause intense immune response and exert an abscopal effect than conventional radiotherapy. Thus, this study is to explore the use of SBRT in combination with ICI in colorectal cancer patients with oligometastasis, in order to get better local and systemic tumor control and improve progress-free survival (PFS). |
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Detailed Description | The investigators plan to recruit patients with mCRC, who have received first-line systemic therapy for more than 3 months and achieved PR/SD. Than all the patients will receive SBRT followed by ICI therapy. | ||||||||
Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Intervention Model Description: All enrolled patients will receive Toripalimab following stereotactic body radiotherapy Masking: None (Open Label)Primary Purpose: Treatment |
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Condition ICMJE | Metastatic Colorectal Cancer | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: SBRT+Toripalimab
Participants received SBRT (BED>80Gy) to oligometastatic lesions and then receive Toripalimab (240mg)/q3w till progression of disease.
Interventions:
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
40 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | September 1, 2021 | ||||||||
Estimated Primary Completion Date | March 1, 2021 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03927898 | ||||||||
Other Study ID Numbers ICMJE | 18-223/1781 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Jing Jin, M.D., Chinese Academy of Medical Sciences | ||||||||
Study Sponsor ICMJE | Chinese Academy of Medical Sciences | ||||||||
Collaborators ICMJE | Shanghai Junshi Bioscience Co., Ltd. | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Chinese Academy of Medical Sciences | ||||||||
Verification Date | April 2019 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |