The Combination of Immunotherapy and Stereotactic Ablative Radiotherapy in MSS Oligometastatic Colorectal Cancer

Program Status

Recruiting

Phase

Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

Sintilimab

Tags

MSS/ MMRp
Location Location Status
China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
Recruiting

Contacts

Zhen Zhang, MD, PhD
Contact
18801735029 zhen_zhang@fudan.edu.cn

Inclusion Criteria

Inclusion Criteria:

Aged 18-70 years old, regardless of gender
Fully informed and willing to provide written informed consent for the trial
ECOG performance status 0-1
Has an investigator determined life expectancy of at least 6 months
Histologically confirmed colorectal adenocarcinoma, with MSS or pMMR status
Has 2-5 measurable metastatic lesions detected on imaging, with none of them indicated for surgery; or the participant refuses to receive surgery. Biopsy of metastasis is preferred, but not required
Has undergone at least one dose of first-line systemic chemotherapy, except for any type of immunotherapy
Multiple sites of lesions can be safely treated by SABR, and at least one lesion spared from irradiation, so as for assessment. The maximum diameter of each lesion for irradiation is no more than 5cm.
Demonstrate adequate organ function
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Exclusion Criteria

Exclusion Criteria:

Pregnant or lactating women
Serious medical comorbidities precluding radiotherapy
Prior radiotherapy to a site requiring treatment
Malignant pleural effusion
Inability to treat all sites of active disease
Has clinical or radiologic evidence of spinal cord compression or tumor within 3mm of spinal cord on MRI.
Dominant brain metastasis requiring surgical decompression
Has prior treatment with cancer immunotherapy including, but not limited to immune checkpoint inhibitors.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at a dose of >10 mg Prednisone daily or equivalent at time of trial treatment.
Has a known history of active Bacillus Tuberculosis
Has active autoimmune disease that has required systemic treatment in the past 2 years
Hypersensitivity to PD-1 inhibitor or any of its excipients.
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered from adverse events due to a previously administered agent.

NCT ID

NCT04535024

Date Trial Added

2020-09-01

Updated Date

2021-05-11