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

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, single-center, single-arm phase II clinical trial. This study aims to evaluate the safety and tolerability of stereotactic ablative radiotherapy (SABR) in combination with Sintilimab, and to examine the impact of the combination therapy on tumor control, long-term survival and quality of life in patients with microsatellite stable (MSS) oligometastatic colorectal cancer.

A total of 60 MSS oligometastatic colorectal cancer patients will be recruited and receive multisite SABR followed by immunotherapy of Sintilimab within one week from completion. Sintilimab will be given at a fixed dose of 200mg (100mg if weight < 50 kg) via intravenous infusion on the first day of each cycle, repeated every three weeks. The dosing will continue for up to two years until disease progression, unacceptable toxicity or patient withdrawal. The tumor regression, disease control, adverse events and long-term survival will be analyzed.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University

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:

• 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.