Abscopal Effect of Radiation in Combination With rhGM-CSF for Metastatic Non-small Cell Lung Cancer

NCT ID: NCT03113851

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-14
• Study Completion Date: 2018-10-14

Brief Summary

The purpose of this study is to determine whether radiation combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) is safe and effective for patients with metastatic non-small cell lung cancer.

Detailed Description

The prognosis of patients with metastatic non-small cell lung cancer was still poor for those unsuitable for target therapy or immunotherapy. This study is to include patients evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy to evaluate the efficacy and safety of receiving radiotherapy combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF).

Conditions

Lung Cancer Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiotherapy and rhGM-CSF

Patients with metastatic non-small cell lung cancer received 3.5 Gy per fraction to a total dose of 35 Gy/ 10 fractions over 2 weeks, combined with rhGM-CSF (125 μg/m2).

Group Type: EXPERIMENTAL

Radiotherapy

Intervention Type: RADIATION

One lesion received radiotherapy for 35 Gy in 10 fractions and rested for one week; then another metastatic lesion were treated with radiotherapy for 35 Gy in 10 fractions.

rhGM-CSF

Intervention Type: DRUG

Patients were injected subcutaneously rhGM-CSF 125mg/m2 per day from day1 to day 14, every three weeks, concurrent with radiotherapy

Interventions

Radiotherapy

One lesion received radiotherapy for 35 Gy in 10 fractions and rested for one week; then another metastatic lesion were treated with radiotherapy for 35 Gy in 10 fractions.

Intervention Type: RADIATION

rhGM-CSF

Patients were injected subcutaneously rhGM-CSF 125mg/m2 per day from day1 to day 14, every three weeks, concurrent with radiotherapy

Intervention Type: DRUG

Other Intervention Names

radiation; recombinant human GM-CSF

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years;

2. Histologically proven non-small-cell lung cancer；

3. Stage IV according to UICC stage system(version 7,2009), at least with three evaluable abscopal lesions (≥1cm)（excluding intestinal metastasis）;

4. Evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy (progression sites were no more than three sites);

5. ECOG performance status: 0-1;

6. Life expectancy ≥ 3 months.

7. Adequate baseline organ and marrow function: absolute neutrophil count greater than 1500 cells per μL, platelet concentration of greater than 50 000 per μL, total bilirubin less than 1•5 times the upper limit of normal (ULN), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the ULN, and serum creatinine less than 1•5 times the ULN;

8. Female subjects have a negative urine or serum pregnancy test within 1 week prior to treatment if of childbearing potential;

9. Asymptomatic subjects with brain metastasis can be included, but the sites of brain cannot be considered as target sites;

10. Asymptomatic subjects with bone metastasis can be included, but the sites of bone cannot be considered as target sites.

Exclusion Criteria

1. Having received immunotherapy within 4 weeks prior to inclusion;

2. Allergic to GM-CSF, or diagnosed with immune system disease, receiving immunosuppressant, such as prednisone, dexamethasone, methylprednisolone, methotrexate, hydroxychloroquine, cyclophosphamide, azathioprine and so one;

3. receiving treatment of other trials;

4. Any unstable systemic disease, including active infection, symptomatic congestive heart failure, myocardial infarction onset six months before included into the group, unstable angina, and severe arrhythmia, uncontrolled chronic lung disease;

5. unwilling to sign consent;

6. Women in pregnancy or lactation;

7. Other malignancy except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Anhui Shi, MD

Associate Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anhui Shi, MD.

Role: PRINCIPAL_INVESTIGATOR

Peking University Cancer Hospital & Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

2016YJZ23

Identifier Type: -

Identifier Source: org_study_id