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High- and Low-dose Radiotherapy Combined With Envafolimab for Metastatic Solid Tumor

China33 participantsStarted 2023-03-01

Plain-language summary

The purpose of this study is to explore the efficacy and safety of high- and low-dose radiotherapy (HD-RT/LD-RT) combined with envafolimab (I) in the treatment of metastatic solid tumors that have failed first-line immunotherapy or above.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓. Patients with metastasis (including recurrence) solid tumors and failure with first-line or above immunotherapy (PD-1/PD-L1/CTLA-4 inhibitors), and no subsequent standard treatment regimen.
✓. Previous histopathologic confirmation of malignancy.
✓. Tumor diameter \> 5 cm or the number of metastases is 6-15 (at least one measurable lesion, bone metastases are not used as target lesions), not suitable for conventional radiotherapy, surgery, radiofrequency ablation, and other treatments.
✓. Patients with an ECOG score of 0 or 1, and an expected survival period of ≥6 months.
✓. 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.
✓. 18-70 years old, no gender limit.

What they're measuring

Objective response rate (ORR)

Timeframe: 6 months

Trial details

NCT IDNCT05755009

SponsorJiangxi Provincial Cancer Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-20

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