Combination of High and Low-Dose Radiotherapy With Immune Therapy and TKI in Advanced Colorectal … (NCT07467590) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Combination of High and Low-Dose Radiotherapy With Immune Therapy and TKI in Advanced Colorectal Cancer: A Phase II Study
33 participantsStarted 2026-04-01
Plain-language summary
The goal of this clinical trial is to learn whether a high- and low-dose radiotherapy regimen followed by anti-angiogenic TKI and anti-PD-1 antibody therapy works to treat advanced metastatic colorectal cancer. It will also evaluate long-term survival outcomes and explore potential biomarkers associated with tumor response and immune modulation.
The main questions it aims to answer are:
Does the high- and low-dose radiotherapy regimen followed by sequential anti-angiogenic TKI and anti-PD-1 therapy improve the objective response rate (ORR) in patients with advanced metastatic colorectal cancer?
What are the disease control rate (DCR) and survival outcomes following this treatment strategy?
Are tumor response and long-term survival associated with specific biomarkers related to systemic immune modulation induced by radiotherapy to different metastatic organs?
How does this radiotherapy pattern affect tumor immune infiltration in metastatic lesions?
This is a single-arm, single-center, prospective Phase II clinical study designed to evaluate the efficacy of a high- and low-dose radiotherapy regimen targeting metastatic lesions followed by sequential anti-angiogenic TKI and anti-PD-1 antibody therapy in patients with advanced metastatic colorectal cancer.
Participants will:
Receive high- and low-dose radiotherapy to metastatic lesions. Subsequently receive anti-angiogenic TKI combined with anti-PD-1 antibody therapy.
Undergo regular clinical assessments and imaging evaluations to determine tumor response.
Provide blood and tumor samples for biomarker and immune infiltration analysis. Be followed for survival outcomes and disease progression.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Ability to understand and willingness to sign a written informed consent form.
✓. Clinical stage IV disease confirmed by systemic imaging. At least two measurable metastatic lesions per RECIST 1.1, including:
✓. Failure after first-line triplet chemotherapy containing platinum and irinotecan; Or failure after first-line platinum-based chemotherapy followed by second-line irinotecan-based chemotherapy.
✓. Ability to swallow oral medication.
✓. ECOG performance status 0-1.
✓. Adequate organ function as defined by laboratory criteria.
Exclusion criteria
✕. History of severe hypersensitivity to monoclonal antibodies or anti-angiogenic agents.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: At the end of 2 treatment cycles (approximately 6-8 weeks after treatment initiation)
Trial details
NCT IDNCT07467590
SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University
. Prior exposure to immune checkpoint inhibitors (including anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., targeting ICOS, CD40, CD137, GITR, OX40), or any prior cancer immunotherapy.
✕. Active autoimmune disease or history of autoimmune disease, including but not limited to interstitial pneumonitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism (patients on stable hormone replacement therapy may be eligible). Patients with psoriasis or childhood asthma/allergy that has completely resolved and requires no adult intervention may be eligible; patients requiring bronchodilator therapy are excluded.
✕. History of immunodeficiency, including positive HIV test, congenital or acquired immunodeficiency, prior organ transplantation, or allogeneic bone marrow transplantation.