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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

Phase II Study of Toripalimab Plus Stereotactic Body Radiotherapy in Colorectal Cancer Patients With Oligometastasis

Clinicaltrials.gov identifier NCT03927898

Recruitment Status Recruiting

First Posted April 25, 2019

Last update posted April 25, 2019

Study Description

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).

  • Condition or Disease:Metastatic Colorectal Cancer
  • Intervention/Treatment: Drug: Toripalimab
    Radiation: Stereotactic Body Radiotherapy
  • Phase: Phase 2
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 40 participants
  • 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 2019
  • Estimated Primary Completion Date: March 2021
  • Estimated Study Completion Date: September 2021
Arms and interventions
Arm Intervention/treatment
Experimental: SBRT+Toripalimab
Participants received SBRT (BED>80Gy) to oligometastatic lesions and then receive Toripalimab (240mg)/q3w till progression of disease.
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
Outcome Measures
  • Primary Outcome Measures: 1. 1 year Progression-Free-Survival (PFS) [ Time Frame: 1 year ]
    1 year PFS
  • Secondary Outcome Measures: 1. Grade 3-5 acute adverse events [ Time Frame: 6 months since last treatment of Toripalimab ]
    Grade 3-5 acute adverse events
  • 2. Objective response rate [ Time Frame: At the end of 4 cycles of Toripalimab (each cycle is 21 days) ]
    Objective response rate
  • 3. 2 year local control rate [ Time Frame: 2 year ]
    2 year local control rate
  • 4. 2 year overall survival [ Time Frame: 2 year ]
    2 year overall survival
  • 5. T cell receptor repertoire and T cell clones in peripheral blood [ Time Frame: At the end of 6 cycles of Toripalimab (each cycle is 21 days) ]
    Change of T cell receptor repertoire and T cell clones in peripheral blood
  • 6. Expression of PD-1, ki-67 on T cell [ Time Frame: At the end of 6 cycles of Toripalimab (each cycle is 21 days) ]
    Change of expression of PD-1, ki-67 on T cell
  • 7. Expression of PD-L1 on Exosomes in peripheral blood [ Time Frame: At the end of 6 cycles of Toripalimab (each cycle is 21 days) ]
    Change of expression of PD-L1 on Exosomes in peripheral blood
  • 8. Expression of PD-L1 on circulation tumor cell [ Time Frame: At the end of 6 cycles of Toripalimab (each cycle is 21 days) ]
    Change of expression of PD-L1 on circulation tumor cell
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

1. Age:18-75 years old , Eastern Cooperative Oncology Group (ECOG) performance status of
0-1

2. Histologically confirmed CRC , metastatic CRC , subjects have received first-line
systemic therapy for more than 3 months and achieved PR/SD, the interval between last
systemic therapy and SBRT is≥4 weeks

3. The primary site has been controlled by surgery

4. Patient has at least 1 lesion of measurable metastatic disease by Response Evaluation
Criteria in Solid Tumors (RECIST) version 1.1 and iRECIST , and who can achieve the
status of non evidence of disease after local ablative therapy. The number of lesion
is ≤ 5, the maximum diameter of the lesion is ≤5cm ,

5. All metastatic lesions are amenable to SBRT with BED≥80Gy in 3 to 5 fractions;

6. Have a life expectancy of at least 6 months

7. 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

8. patients and his/her mate must agree to follow instructions for method(s) of
contraception for the duration of treatment with study drug;

9. Patient must have the ability to understand and the willingness to sign a written
informed consent document.

Exclusion Criteria:

1. Serious autoimmune disease at the discretion of the treating attending,subjects with
leukodermia,allergic asthma syndrome will not be excluded from the study.

2. Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis.

3. Has evidence of interstitial lung disease or active, non-infectious pneumonitis
requiring systemic steroids.

4. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any
other form of immunosuppressive therapy within 7 days prior to study Day 1 of the
trial treatment.

5. Has a known additional malignancy,subjects with basal cell carcinoma (BCC), squamous
cell carcinoma of skin and carcinoma in situ of cervix will not be excluded from the
study.

6. Has received a vaccine within 30 days prior to study Day 1 of the trial treatment or
will receive a vaccine after the trial treatment; active HBV,HCV infection

7. 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.

8. Any underlying medical or psychiatric condition: partial endocrine organ deficiencies
, serious cardiac,pulmonary,renal disease,active infectious disease.

9. Active diverticulitis, intra-abdominal abscess, Gastrointestinal (GI) obstruction,
abdominal carcinomatosis , frequent diarrhea or other known risk factors for bowel
perforation.

Contacts and Locations
Contacts

Contact: Jing Jin, M.D +86-1087787568 jingjin1025@163.com

Contact: Jianyang Wang, M.D. +86-1087788122 pkucell@163.com

Locations

China, Beijing
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing

China, Beijing
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing

China
Department of Radiation Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Beijing

Sponsors and Collaborators

Chinese Academy of Medical Sciences

Shanghai Junshi Bioscience Co., Ltd.

More Information