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A Phase II, single-arm, prospective study of stereotactic radiosurgery with concurrent adjuvant PD-1 antibody Camrelizumab in patients with advanced Chordoma

A Phase II, single-arm, prospective study of stereotactic radiosurgery with concurrent adjuvant PD-1 antibody Camrelizumab in patients with advanced Chordoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036415
Enrollment
Unknown
Registered
2020-08-23
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

advanced chordoma

Interventions

1:stereotactic radiosurgery
1:Camrelizumab

Sponsors

Shanghai Changzheng hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years old male or female; 2. Recurrent chordoma or metastatic chordoma confirmed by histopathology and / or cytology; 3. Tumor progression was detected by enhanced CT / MRI within 6 months before admission; 4. Past treatment history can be inquired (including previous treatment, medication, medication time, disease progression time), and measurable lesions can be judged according to recist1.1 standard; 5. The score of ECoG 0-2; 6. Liver, kidney and hematological functions as required; (1) Blood routine examination should be consistent with (no blood transfusion within 14 days); HB>=90g/L; ANC >=1.5x10^9/L; PLT >=80x10^9/L; (2) Biochemical examination should meet the following standards: Bil =50ml/min (Cockcroft Gault formula); 7. The pregnant test (serum or urine) results of fertile women within 7 days before enrollment were negative, and they voluntarily used appropriate contraceptive methods during the observation period and within 5 months after the last administration of carrizumab; for men, they should be sterilized by surgery or agree to use appropriate contraceptive methods during the observation period and within 7 months after the last administration of carrizumab; 8. No autoimmune diseases; 9. The expected survival time of the patients is more than 3 months; 10. With my consent and informed consent, I am willing and able to follow the planned visit, research treatment, laboratory examination and other test procedure.

Exclusion criteria

Exclusion criteria: 1. Received chemotherapy or targeted therapy within 21 days before enrollment; 2. Received study drug treatment within 21 days before enrollment; 3. Have received anti-PD-1, anti-PD-L1, anti-PD-L2 antibody treatment; 4. Those who have mental illness or do not cooperate; 5. Those who are known to be allergic to calicizumab or similar drugs and their components; 6. Pregnant or lactating women; 7. HIV infection, HBV antibody positive and HBV DNA copy number positive, HCV antibody positive and HCV RNA higher than the detection limit of the analysis method; 8. Patients with previous autoimmune diseases or who have received organ transplantation; 9. Patients who need long-term immunosuppressive therapy (equivalent prednisone dosage >=10mg per day) or immunosuppressant treatment within 14 days before enrollment; patients who need inhaled equivalent dose of prednisone hormone for non autoimmune diseases can be accepted; 10. Received anti infection vaccination within 4 weeks before treatment with carrizumab; 11. Have received radiotherapy of >=8000 cGy (200cgy fraction) in the past; 12. Patients who had received radiotherapy within 6 months before enrollment; 13. Patients who cannot complete radiotherapy; 14. Patients who cannot be visited after treatment; 15. Patients who had been diagnosed with any other tumor within 2 years prior to enrollment, except for basal cell or squamous skin cancer or carcinoma in situ of the cervix after adequate treatment; 16. Patients whose participation in the trial is not in the best interests of the subjects or in any situation that would interfere with the evaluation of the trial protocol.

Design outcomes

Primary

MeasureTime frame
PFS;obsjective response rate;

Secondary

MeasureTime frame
Overall survival;adverse event;DCR;

Countries

China

Contacts

Public ContactCheng Yang

Shanghai Changzheng hospital

15821055604@163.com+86 18601770909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026