Department of Neurosurgery Xuanwu Hospital July 12, 2024, 18:31 Beijing

Dear chordoma patients and their families:

    If you or a family member has been diagnosed with chordoma and has relapsed after surgical treatment, please pay close attention to this clinical research recruitment information. You are invited to participate in a clinical study on “Carfilzomib in Combination with Apatinib for Recurrent Chordoma”. This study was initiated by Professor Chen Zan of the Department of Neurosurgery at Xuanwu Hospital. It aims to control the recurrence and progression of chordoma through combined immunotherapy and targeted therapy drugs, providing more treatment options for patients with recurrent chordoma.

 Chordoma is a relatively rare malignant tumor that commonly occurs in the skull base, the slope, and the sacrum. Although this tumor grows relatively slowly, it often causes pain and neurological dysfunction in patients due to its strong local invasion, such as limb sensory motor dysfunction and paralysis, which seriously affects the quality of life of patients and even threatens their lives.

    The main treatment for chordoma is surgery, but due to the particularity and complexity of the anatomical structure of the spine, it is often difficult to completely remove the tumor during surgery, especially when the tumor is located near important nerve structures. This leads to a high rate of postoperative recurrence of chordoma and poor long-term efficacy. In addition to surgery, radiotherapy and chemotherapy are also used to treat chordoma, but for recurrent or difficult-to-resect chordoma, treatment options are limited and the results are not always ideal. The team of Professor Chen Zan from the Department of Neurosurgery at Xuanwu Hospital, Capital Medical University has extensive experience in the surgical treatment of chordoma, but in the face of many recurrent chordoma patients, they still cannot avoid the problems of increased surgical risks, unsatisfactory surgical results, and limited treatment options. Therefore, this team hopes to explore a new combination drug treatment plan through this study, with the aim of controlling the rate of disease progression, achieving non-surgical control, and improving the quality of life and treatment effect of patients.

1. Project information overview

    Project name: A study of the safety and efficacy of the combination of camrelizumab and apatinib for the treatment of recurrent chordoma

    Project leader: Chen Zan (Senior Consultant Neurosurgeon, Department of Neurosurgery, Xuanwu Hospital, Capital Medical University)

    Project lead unit: Xuanwu Hospital, Capital Medical University

    Participating unit: Beijing Jian Gong Hospital

    Planned number of enrolled patients: 30

    Study drugs: Carfilzomib (PD-1 antibody SHR-1210) and Apatinib Mesylate Tablets.

    Study objective: To evaluate the safety and efficacy of carfilzomib in combination with apatinib in patients with recurrent chordoma.

2. Project registration information

   Approved No. of Clinical Ethics of Xuanwu Hospital, Capital Medical University: Approved No. [2023] 243-003.

    Beijing Jian Gong Hospital Clinical Ethics Review Approval No.:

    Clinicaltrials registration number: NCT06140732.

    Chinese Clinical Trial Registry registration number: ChiCTR2400084482.

    Policy number for patients enrolled in clinical research: PZXY202432070000000011.

3. Enrollment conditions

    1. Age ≥ 18 years, male or female.

    2. Patients with recurrent chordoma confirmed by pathology.

    3. At least one radiologically measurable lesion.

    4. The tumor does not affect the function of organs other than the affected organs.

   5. The subject voluntarily joins the study, signs a written informed consent, has good compliance, cooperates with treatment and follow-up.

4. Exclusion criteria

    1. Those who have serious cardiovascular disease or uncontrolled hypertension.

    2. Patients with active autoimmune disease or a history of autoimmune disease.

    3. Those who have previously received immune checkpoint inhibitor therapy or have allergic manifestations to clinical research drugs.

    4. Pregnant or breastfeeding women.

    5. Patients who cannot cooperate with treatment and follow-up for at least 12 months.

    6. Any other patients who do not meet the enrollment criteria.

5. Your participation will involve

   1. Receiving treatment with carfilzomib (once every two weeks) and apatinib (once daily).

    2. Regular blood, urine and imaging tests to monitor the efficacy of treatment and adverse reactions.

    3. Safety follow-up and survival follow-up for 12 months.

6. Risks and adverse reactions

   Participation in this study may expose you to the following risks and adverse reactions:

    1. Common adverse reactions: rash, fatigue, loss of appetite, elevated blood pressure, elevated urinary protein, red and swollen hands and feet, etc.

    2. Serious adverse reactions: including but not limited to severe hypertension, abnormal liver function, proteinuria and diarrhea, etc. Most of these reactions occur within 1 month of treatment initiation and can be controlled and reversed by temporarily suspending the drug, adjusting the dose, and treating the symptoms.

7. Your benefits

   By participating in this study, you may receive the following benefits:

    1. Therapeutic benefits: Combination therapy may help control the disease and improve quality of life.

    2. Financial benefits: The study provides drugs and free medical insurance to reduce your treatment costs.

    3. Medical support: You will receive follow-up and assessment from a team of professional doctors from the Department of Neurosurgery at Xuanwu Hospital of Capital Medical University and Beijing Jian Gong Hospital, and adverse reactions will be dealt with in a timely manner.

8. Your responsibilities

   1. Strictly follow the treatment and follow-up arrangements, take medication and receive examinations on time.

    2. Report any discomfort or side effects in a timely manner.

    3. If there is a change in your health status (such as a new illness or pregnancy) during the medication period, inform the study doctor in a timely manner.

Contact

If you would like to participate in a clinical study or have any questions, please contact the research team:

Liu Penghao, Department of Neurosurgery, Xuanwu Hospital, Capital Medical University

Phone: 86-17604300002

Email: liuph14@hotmail.com

Xu Zhuofan, Department of Neurosurgery, Xuanwu Hospital, Capital Medical University

Phone: 86-18143303961

Email: zhuofanxu0128@sina.com

Postal address: Xuanwu Hospital, Capital Medical University, 45 Changchun Street, Xicheng District, Beijing