Pilot Study of Anlotinib With STUPP Regimen for Patients With Newly Diagnosed Glioblastoma

NCT04119674 | Completed Phase 1

• 1 other identifier: GBM-AS
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the the efficacy and safety of Anlotinib in combination with STUPP regimen for patients with newly diagnosed glioblastoma.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• PFS

  Progression-Free Survival

  from enrollment to progression or death (for any reason),assessed up to 18months

Secondary Outcomes (4)

• OS

  from enrollment to death (for any reason).assessed up to 24 months

• adverse event

  from enrollment to death (for any reason).assessed up to 24 months

• Health-related quality of life

  from enrollment to death (for any reason).assessed up to 24 months

• Neurocognitive function

  from enrollment to death (for any reason).assessed up to 24 months

Study Arms (1)

single-arm

EXPERIMENTAL

single-arm Drug: Anlotinib Drug: Temozolomide Radiotherapy:Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.

Drug: Drug is Anlotinib.; Drug: Drug is Temozolomide Capsule.; Radiation: Radiotherapy was initiated 4 to 6 weeks postoperatively.

Interventions

Drug is Anlotinib. DRUG

Anlotinib 8 mg/day (Chia-tai Tianqing Pharmaceutical Co., Ltd.) was given orally on days 1 to 14 per 3-week cycle for 2 cycles during concomitant therapy and maximally 8 cycles during adjuvant chemotherapy. One week after discontinuation of adjuvant chemotherapy, anlotinib 8 mg/day was given for maintenance .

single-arm

Drug is Temozolomide Capsule. DRUG

Temozolomide 75 mg/m2/day was taken for maximally 49 days during concurrent chemoradiotherapy. Beginning 4 weeks after completion of concurrent chemoradiotherapy, patients received adjuvant temozolomide for 5 days every 28 days, first cycle 150 mg/m2/day and subsequent cycles 200 mg/m2/day for maximally 6 cycles .

single-arm

Radiotherapy was initiated 4 to 6 weeks postoperatively. RADIATION

Radiotherapy was initiated 4 to 6 weeks postoperatively at a dose of 1.8-2.0 Grays (Gy) per fraction for 5 days per week for 6 weeks with a total dose of 54-60 Gy.

single-arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary, pathologically confirmed glioblastoma, and complete molecular biological marker tests (MGMT, 1p/19q, IDH, TERT, BRAF, p53, EGFR);
• \~ 6 weeks after operation; the surgical incision healed well;
• Presence of lesions evaluable according to Rano criteria;
• Aged 18-70 years;
• Karnofsky performance status (KPS) ≥ 60;
• The dose of corticosteroid therapy was stable or gradually reduced in the past 5 days;
• No previous radiotherapy, chemotherapy, immunotherapy, or biologic therapy;
• Serum hemoglobin ≥ 100 g/L, platelet count ≥ 80 × 109/L, neutrophil count ≥ 1.5 × 109/L;
• Serum creatinine ≤ 1.25 × ULN or creatinine clearance ≥ 60 mL/min;
• Serum bilirubin ≤ 1.5 × ULN, AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN, alkaline phosphatase ≤ 5 × ULN;
• Normal coagulation function (PT prolongation does not exceed 3s, APTT prolongation does not exceed 10s);
• Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial and 8 days after administration of the trial drug. Males must agree to use an appropriate method of contraception or be surgically sterile during the trial and after 8 weeks of trial drug administration;
• Patient is sufficiently compliant with study and follow-up procedures;
• Patients signed a formal informed consent form to indicate that they understood that the study was in accordance with hospital policy and ethical requirements.

You may not qualify if:

• Secondary glioblastoma;
• Patients with any other malignant tumor before or now, except skin non-melanotic carcinoma or cervical carcinoma in situ;
• Any other diseases or conditions are contraindications to chemoradiotherapy (such as active phase of infection, within 6 months after cerebral myocardial infarction, symptomatic heart disease including unstable angina pectoris, congestive heart failure or uncontrolled arrhythmia, immunosuppressive therapy);
• Pregnant or lactating women;
• Women and men who are likely to become pregnant but are unwilling to take appropriate contraceptive measures;
• Evidence of hereditary bleeding constitution or coagulation disorders;
• Patients requiring anticoagulant therapy due to other diseases;

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang cancer hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Chen Ming

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 6, 2019
• First Posted: October 8, 2019
• Study Start: March 19, 2019
• Primary Completion: August 23, 2022
• Study Completion: August 23, 2022
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)