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

Estado del programa

Reclutamiento

Fase

Fase 2

Inmunoterapia previa permitida

No

Ensayo dirigido por el CRC

Drogas

Sintilimab

Etiquetas

MSS/ MMRp
Ubicación Situación
China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai 200032
Reclutamiento

Contactos

Zhen Zhang, MD, PhD
Póngase en contacto con
18801735029 zhen_zhang@fudan.edu.cn

Criterios de inclusión

Criterios de inclusión:

Aged 18-70 years old, regardless of gender
Fully informed and willing to provide written informed consent for the trial
Estado funcional ECOG 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

Criterios de exclusión

Criterios de exclusión:

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

Fecha en que se añadió el juicio

2020-09-01

Fecha de actualización

2021-05-11