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SBRT Plus Anlotinib and Bimepolizumab in Locally Advanced or Metastatic Renal Cell Carcinoma

ConditionLocally Advanced or Metastatic Renal Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorFujian Cancer Hospital

About this trial

To investigate the objective response rate (ORR) of stereotactic body radiotherapy (SBRT) combined with anlotinib and beromuzumab in locally advanced/metastatic renal cell carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 80 years, regardless of sex.

Histologically or cytologically confirmed locally advanced/metastatic renal cell carcinoma (RCC) inoperable/refused for surgery, or post-operative locally recurrent/metastatic RCC; pathological types include clear cell carcinoma and papillary renal cell carcinoma.

ECOG performance status 0 or 1.

At least 50% of all evaluable metastatic lesions are eligible for stereotactic body radiation therapy (SBRT).

Disqualifiers

With contraindications to targeted or immunotherapeutic drugs.

A history of other malignant diseases in the recent 5 years, except for cured skin cancer and carcinoma in situ of the cervix.

With active autoimmune diseases, organ transplantation, or other diseases requiring immunosuppressive therapy or long-term hormone therapy.

Extensive diffuse metastasis with an expected survival of less than 3 months.

Trial design

Design model

Single group

Treatments tested in this trial

  • Stereotactic Body Radiation Therapy (SBRT)

    Radiation

    Dose fractionation: 39-48Gy/3f or 40-50Gy/5f, alternative 20-50Gy/5f if OAR dose-limited. Dose adjusted per radiation toxicities during treatment.

  • Anlotinib

    Drug

    Oral anti-angiogenic agent, 12 mg qd fasting, 21d/cycle (2w on/1w off)

  • Bemarituzumab

    Drug

    Intravenous PD-1 inhibitor, 1200 mg q3w, 60min infusion

Treatment groups

27 Participants
are divided into 1 treatment group
Group A: SBRT combined with Anlotinib and BemarituzumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Time frame
Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and at regular intervals during consolidation therapy follow-up throughout the study, from enrollment to 36 month.

Secondary outcomes

1

Progression-Free Survival (PFS)

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
2

Disease Control Rate (DCR)

Time frame
Assessed at baseline, before the second/fourth cycle of targeted-immunotherapy and regular follow-up during consolidation therapy, from enrollment to 36 month.
3

Overall Survival (OS)

Time frame
Followed up for the entire study period until patient death or study conclusion, from enrollment to 36 month.
4

Objective Response Rate in the Field of Irradiation

Time frame
Assessed at baseline, post-SBRT (before the 2nd cycle of targeted-immunotherapy) and regular follow-up during consolidation therapy, from enrollment to 36 month..

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fujian Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: