Chordoma, Chemotherapy Effect
Conditions
Brief 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.
Detailed description
PRIMARY OBJECTIVES: I. To assess the clinical benefit of the combination of Camrelizumab combined with Apatinib in patients with advanced chordomas by adverse events (AEs) and progression free survival (PFS). SECONDARY OBJECTIVES: I. Ascertain the safety of nivolumab in combination with relatlimab in subjects with metastatic or locally advanced/unresectable chordoma by the Overall survival (OS), objective response rate (MPR) and disease control rate (DCR) EXPLORATORY OBJECTIVES: I. Compare response rate (RR) and clinical benefit rate (CBR) in patients whose tumors are PD-L1+ and PD-L1- at baseline. II. Compare RR and CBR in patients whose tumors are VEGFR+ and VEGFR- at baseline. III. In the patients who are PD-L1 positive, compare RR and CBR in patients with 1% and 5% tumor membrane staining. III. Determine the response to treatment based on the baseline mutation load. IV. Determine the ORR and CBR via Choi criteria. OUTLINE: To evaluate the safety and tolerability of carrilizol combined with apatinib in patients with recurrent, unresectable, chemotherapy-failed chordoma After completion of study treatment, participants are followed up within 3 months.
Interventions
camrelizumab 200 mg iv/ q2w+ apatinib 375mg oral qd
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
camrelizumab 200 mg iv/ q2w+ apatinib 375mg oral qd
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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: 1. 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) : 1. Hemoglobin (Hb) ≥ 80 g/L; 2. Neutrophil count (ANC) ≥ 1.5×109/L; 3. Platelet count (PLT) ≥ 80×109/L; 2. Biochemical examination shall meet the following standards: 1. Total bilirubin (TBIL) \< 1.5 ULN; 2. ALT and AST \< 2.5ULN, and \< 5ULN in patients with liver metastasis; Alkaline phosphatase \< 5ULN; 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness: Progression-free survival (PFS) | 6 months | To assess the clinical benefit of the combination of Camrelizumab combined with Apatinib in patients with advanced chordomas by adverse event and Progression-free survival. |
| Incidence and severity of AE | From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year). | To assess the clinical benefit of the combination of Camrelizumab combined with Apatinib in patients with advanced chordomas by adverse event and Progression-free survival. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS), , disease | From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year). | To assess the clinical benefit of the combination of Camrelizumab combined with Apatinib in patients with advanced chordomas by Overall survival (OS). |
| Objective response rate (OPR) | From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year). | To assess the clinical benefit of the combination of Camrelizumab combined with Apatinib in patients with advanced chordomas by objective response rate (OPR) |
| Control rate (DCR) | From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year). | To assess the clinical benefit of the combination of Camrelizumab combined with Apatinib in patients with advanced chordomas by disease control rate (DCR). |
Countries
China
Contacts
Primary ContactZan Chen, Dr.
Backup ContactZan Chen
Outcome results
None listed