This is a single-center, open-label, single-arm phase I clinical study to exploratory observe and evaluate the efficacy and safety of anti-PD-1 antibody (Camrelizumab for Injection) combined with multisite stereotactic ablative radiotherapy (SABR) in patients with oligometastatic gastrointestinal cancer. According to the origin site of metastases, this study will consist of three subgroups, including gastric carcinoma group, colorectal carcinoma group and hepatocellular carcinoma group. For each of the subgroup, seven eligible patients with oligometastatic cancer originating from stomach, colon and liver, respectively will be recruited. All patients will receive multisite SABR followed by immunotherapy of Camrelizumab within one week from completion. Camrelizumab will be administered at a fixed dose of 200 mg intravenously (iv) on D1 in a 14-day cycle. The treatment will continue for up to two years until disease progression, unacceptable toxicity or patient withdrawal. Tumor tissue samples, sections, paraffin blocks or biopsy blocks, and biomarkers, including but not limited to PD-L1 expression level and the proportion of positive cells, TMB level and MMR status, will be collected from subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
To irradiate as many metastatic lesions as possible, in the precondition that normal tissues can tolerate. Target dose will be adjusted depending on site of the lesion and organs at risk (BED \> 100Gy). Sequence of irradiation for multiple metastases will be at the discretion of the investigators based on their experience.
Administration of Carrelizumab will be started within one week upon SABR completion, and will be continued for up to two years until disease progression, unacceptable toxicity or patient withdrawal.
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Dose-limiting toxicities (DLT)
Defined as treatment-related Grade 3 or higher toxicities (excluding asymptomatic biochemical abnormalities) within 3 months, starting from the first day of radiotherapy. Toxicities will be assessed and graded according to NCI-CTCAE v5.0.
Time frame: Up to 2 years
Adverse events (AEs)
Assessed according to NCI-CTCAE v5.0., and summarized by type and severity in tabular format to examine their frequency, organ systems affected, severity, and relationship to study treatment.
Time frame: Up to 2 years
Local control (LC)
Defined as stable disease, partial response, or complete response based on serial imaging with CT scan. Recurrence will be defined as a suspicious mass at the site of SABR treated lesion, progressing in size on 2 consecutive computed tomography scans at a minimum interval of 1 month, combined with a positive FDG-PET defined by a SUV max ≥ 5, or a biopsy-proven confirmation.
Time frame: Up to 2 years
Progression-free survival (PFS)
Regional or distant disease progression according to RECIST v1.1 or death due to any cause
Time frame: Up to 2 years
Overall survival (OS)
A subject will be classified as either alive or dead due to any cause. The time to event will be calculated as the time from Day 1 until date of death. Day 1 is the date of 1st treatment with SABR.
Time frame: Up to 2 years
Quality of life assessment
Assessed with the Functional Assessment of Cancer Therapy: General (FACT-G)
Time frame: Up to 2 years
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