High- and Low-dose Radiotherapy Combined With PD-1 Inhibitors for MSS CRLM
NCT ID: NCT06045286
Last Updated: 2023-09-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2023-09-20
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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High- and Low-dose radiotherapy combined with immunotherapy.
All eligible patients will receive high-dose radiotherapy, followed by low-dose radiotherapy combined with PD-1 inhibitor therapy starting within 7 days after completion. The single dose of high-dose radiotherapy will be 6-8 Gy for 3-7 consecutive exposures, and the single dose of low-dose radiotherapy will be 0.5-1.4 Gy for 3-7 consecutive exposures.The PD-1 inhibitor (Zimberelimab) will be administered at the dose recommended in the specification every 3 weeks until disease progression, unacceptable toxicity, and withdrawal of informed consent by the patient.
Radiation: High- and Low-dose radiotherapy
High-dose radiotherapy (6-8Gy×3-7F) followed by low-dose radiotherapy (0.5-1.4Gy×3-7F) starting within 7 days after completion.
PD-1 Inhibitors
Immunotherapy (Zimberelimab) is given every three weeks within one week after the end of high-dose radiotherapy.
Interventions
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Radiation: High- and Low-dose radiotherapy
High-dose radiotherapy (6-8Gy×3-7F) followed by low-dose radiotherapy (0.5-1.4Gy×3-7F) starting within 7 days after completion.
PD-1 Inhibitors
Immunotherapy (Zimberelimab) is given every three weeks within one week after the end of high-dose radiotherapy.
Eligibility Criteria
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Inclusion Criteria
2. Patients with an ECOG score of 0 or 1, and an expected survival period of ≥6 months.
3. During the study, they are willing to follow the arrangement and not use other systemic anti-tumor drugs such as chemotherapy, targeted, Chinese herbal medicine, and proprietary Chinese medicine.
4. 18-70 years old, no gender limit.
Exclusion Criteria
2. Cancer patients who require urgent surgical intervention, such as high-risk pathological fractures, life-threatening bleeding symptoms, etc.
3. Any of the following conditions in the 6 months before screening: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient cerebral ischemia Onset or symptomatic pulmonary embolism. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria or left ventricular ejection fraction \<50% must adopt an optimized and stable medical plan determined by the treating doctor. If appropriate, you can consult a cardiologist.
4. Patients with active infection requiring systemic treatment.
18 Years
ALL
No
Sponsors
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Jiangsu Cancer Institute & Hospital
OTHER
Responsible Party
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Lijun Wang
Associate Professor
Locations
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Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HaRyPOT
Identifier Type: -
Identifier Source: org_study_id
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