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OncoMatch/Clinical Trials/NCT06114225

Pulmonary Resectable Osteosarcoma Treated by Metastasectomy and Pre-operative Immunotherapy and Stereotactic Body Radiotherapy (PROMIS): a Prospective Clinical Trial

Is NCT06114225 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapy for osteosarcoma.

Phase 2RecruitingRuijin HospitalNCT06114225Data as of Jun 2026Location: China

Treatment: metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapyThe aim of this study is to evaluate the efficacy and safety of pre-operative concurrent Stereotactic Body Radiotherapy (SBRT) and and programmed cell death protein-1 (PD-1) blockade immunotherapy followed by surgical metastasectomy for resectable metastatic osteosarcoma.

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Extracted eligibility criteria

Treatments studied

Chemotherapy

metastasectomy and pre-operative immunotherapy (gemcitabine and penpulimab ) and stereotactic body radiotherapy

Cancer type

Osteosarcoma

Disease stage

Metastatic disease required

Demographics

Ages 10–65

Prior therapy

Min 1 prior line

Must have received: systemic treatment

Participants have received at least one standardized systemic treatment regimen at the time of enrollment

Cannot have received: (gemcitabine)

have not received gemcitabine in the past

Cannot have received: anti-PD-1 therapy

Exception: secondary resistance to the drug (i.e., the best efficacy evaluation is CR, PR or SD lasting more than 4 months, but secondary tumor resistance develops after treatment)

Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or drugs targeting another stimulating or synergistic inhibition of T cell receptors (e.g., CTLA-4, OX-40, CD137) drug and secondary resistance to the drug (i.e., the best efficacy evaluation is CR, PR or SD lasting more than 4 months, but secondary tumor resistance develops after treatment)

Cannot have received:

Received systemic systemic treatment with Chinese patent medicines with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except local use to control pleural effusion) within 2 weeks before the first dose

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06114225 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior , anti-PD-1 therapy, disqualifies patients from enrollment.

Is there an age limit?

Yes. Patients must be 65 years or younger and at least 10 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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Related pages

Osteosarcoma trials