A Single-arm Phase 2 Study of Apatinib (Anti-PD-1) Combined With Camrelizumab (Anti-VEGFR ) in Patients With Advanced Chordoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial studies how well Camrelizumab combined with Apatinib work in treating participants with chordoma that has spread to other places in the body, which may interfere with the ability of tumor cells to grow and spread.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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∙ 1\. Age ≥ 16 years old, male or female; 2. The physical status score of the Eastern Cancer Collaboration Group (ECOG) was 0-1; 3. Expected survival ≥3 months; 4. Patients with advanced chordoma confirmed by histopathology; 5. Imaging was available to evaluate the lesions. According to the evaluation criteria for solid tumor efficacy (RECIST 1.1, see Annex 2), there was at least one single-diameter measurable lesion, whose longest diameter was measured by spiral CT ≥ 10 mm; 6. All acute toxicities resulting from prior antitumor therapy were resolved to grade 0-1 (according to NCI CTCAE version 5.03) or to the level specified in the enrollment/exclusion criteria prior to enrollment (except for toxicities such as alopecia that the investigator determined did not pose a safety risk to the subject); If subjects undergo major surgery, they must have fully recovered from complications before starting treatment; 7. If the major organs function normally, the following criteria are met:

• The standard of blood routine examination should be met (no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulating factors are used to correct) :

‣ Hemoglobin (Hb) ≥ 80 g/L;

⁃ Neutrophil count (ANC) ≥ 1.5×109/L;

⁃ Platelet count (PLT) ≥ 80×109/L;

• Biochemical examination shall meet the following standards:

‣ Total bilirubin (TBIL) \< 1.5 ULN;

⁃ ALT and AST \< 2.5ULN, and \< 5ULN in patients with liver metastasis; Alkaline phosphatase \< 5ULN;

⁃ Serum Cr ≤ ULN or endogenous creatinine clearance \> 45 ml/min. 8. Women of childbearing age must have used reliable contraception or had a pregnancy test (serum or urine) within 7 days prior to enrol, with a negative result, and be willing to use an appropriate method of contraception during the trial period and 60 days after the last dose of the test drug. For men, consent to use appropriate methods of contraception or surgical sterilization during the trial period and for 120 days after the last dose of the trial drug; 9. The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up.

Locations
Other Locations
China
BEIJING
RECRUITING
Beijing
Contact Information
Primary
Zan Chen, Dr.
qimaoyang777@163.com
18131166269
Backup
Zan Chen
chenzan66@163.com
+861391171212
Time Frame
Start Date: 2023-10-30
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 30
Treatments
Experimental: camrelizumab combined with apatinib
camrelizumab 200 mg iv/ q2w+ apatinib 375mg oral qd
Related Therapeutic Areas
Sponsors
Leads: Xuanwu Hospital, Beijing

This content was sourced from clinicaltrials.gov