ChordomaPhase 2NCT06140732
Apatinib Combined With Camrelizumab in Treating Participants With Advanced Chordoma
A Phase 2 study testing camrelizumab and apatinib in people with Chordoma and Chemotherapy Effect, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chordoma, Chemotherapy Effect
- What is being tested?
- camrelizumab and apatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2023to 31 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- Except for those subjects whose toxicity had not recovered from previous antitumor therapy (concurrent chemoradiotherapy, surgical treatment) (alopecia, alkaline phosphatase, glutamine detranspeptase (GGT)) or who could be enrolled after discussion with the investigator and sponsor
- Use of immunosuppressive drugs within 14 days prior to first use of carrilizumab, excluding nasal and inhaled corticosteroids or systemic steroid hormones at physiological doses (i.e., no more than 10 mg/ day of prednisolone or other corticosteroids at pharmacologically equivalent doses);
- Previous treatment with anti-PD-1, anti-PD-L1, anti-VEGFR antibodies or anti-PD-L2 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);
- Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg, despite systematic medication);
- Severe cardiovascular disease: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450 ms for men and ≥470 ms for women); Grade Ⅲ to Ⅳ cardiac insufficiency (according to the New York Heart Society NYHA classification, see Annex 3), or left ventricular ejection fraction (LVEF) < 50% indicated by cardiac color ultrasound;
- Patients with any active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism) are not included;
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- The subjects were treated with bronchodilators and other systemic treatments, but their asthma control was unsatisfactory and they could not be included (those whose asthma had been completely relieved in childhood could be included without any intervention after adulthood).
- Urine routine suggests urinary protein ≥ ++, or confirms 24-hour urinary protein volume ≥1.0g;
- Abnormal coagulation function (INR >1.5 ULN or prothrombin time (PT) > ULN+4 seconds or APTT >1.5 ULN), have a tendency to bleed or are receiving thrombolytic or anticoagulant therapy; Note: Under the premise of INR ≤ 1.5, the use of low dose heparin (adult daily dose of 0.6 thousand to 12 thousand U) or low dose aspirin (daily dose of 100 mg or less) is permitted for preventive purposes;
- A severe infection occurring within 4 weeks prior to the first dose (e.g., requiring intravenous antibiotic, antifungal, or antiviral medication), or an unexplained fever >38.5°C during the screening period/prior to the first dose;
- Severe arteriovenous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 12 months before enrollment;
- Had undergone major surgery or severe traumatic injury, fracture or ulcer within 4 weeks prior to enrollment;
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active tuberculosis, active hepatitis B (HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive, And HCV-RNA is higher than the lower limit of detection method) or co-infected with hepatitis B and hepatitis C;
- Patients with a clear history of allergy may have an underlying allergy or intolerance to the biologics of Apatinib and carrilizumab;
- There are significant factors affecting the absorption of oral drugs, such as inability to swallow, chronic diarrhoea and intestinal obstruction. Or have cavity or perforation of viscera or sinus within 6 months;
- Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
- Increases the risks associated with study participation or study drugs and, in the investigator's judgment, may result in other conditions for which the patient is not eligible for study enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
BEIJING
Beijing, Beijing Municipality
Zan Chen, MD, 13911712120 ext. +86, 13911712120@163.COM
About this study
Official title: A Single-arm Phase 2 Study of Apatinib (Anti-PD-1) Combined With Camrelizumab (Anti-VEGFR ) in Patients With Advanced Chordoma
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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:
- 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.
- Conditions
- Chordoma, Chemotherapy Effect
- Being tested
- camrelizumab and apatinib
- Medical subject headings
- Chordoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
camrelizumab and apatinibDrug
Also called Targeted therapy
camrelizumab 200 mg iv/ q2w+ apatinib 375mg oral qd
| Study group | Role | What they receive |
|---|---|---|
| camrelizumab combined with apatinib | Experimental | camrelizumab 200 mg iv/ q2w+ apatinib 375mg oral qd Receives: Drug: camrelizumab and apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: Progression-free survival (PFS)
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.
Measured: 6 months
Incidence and severity of AE
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.
Measured: From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year).
Secondary outcomes (3)
Overall survival (OS), , disease
To assess the clinical benefit of the combination of Camrelizumab combined with Apatinib in patients with advanced chordomas by Overall survival (OS).
Measured: From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year).
Objective response rate (OPR)
To assess the clinical benefit of the combination of Camrelizumab combined with Apatinib in patients with advanced chordomas by objective response rate (OPR)
Measured: From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year).
Control rate (DCR)
To assess the clinical benefit of the combination of Camrelizumab combined with Apatinib in patients with advanced chordomas by disease control rate (DCR).
Measured: From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start30 Oct 2023
- Primary completion1 Jan 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ChordomaStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- camrelizumab 200 mg iv/ q2w+ apatinib 375mg oral qd
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zan Chen, Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140732
- Sponsor's protocol ID
- XW-NS-ACCFC
- Status last verified
- Oct 2023
- First submitted
- 8 Nov 2023
- Last updated
- 20 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Somaiah N, Conley AP, Parra ER, Lin H, Amini B, Solis Soto L, Salazar R, Barreto C, Chen H, Gite S, Haymaker C, Nassif EF, Bernatchez C, Mitra A, Livingston JA, Ravi V, Araujo DM, Benjamin R, Patel S, Zarzour MA, Sabir S, Lazar AJ, Wang WL, Daw NC, Zhou X, Roland CL, Cooper ZA, Rodriguez-Canales J, Futreal A, Soria JC, Wistuba II, Hwu P. Durvalumab plus tremelimumab in advanced or metastatic soft tissue and bone sarcomas: a single-centre phase 2 trial. Lancet Oncol. 2022 Sep;23(9):1156-1166. doi: 10.1016/S1470-2045(22)00392-8. Epub 2022 Aug 4.
PubMed 35934010Liu C, Jia Q, Wei H, Yang X, Liu T, Zhao J, Ling Y, Wang C, Yu H, Li Z, Jiao J, Wu Z, Yang C, Xiao J. Apatinib in patients with advanced chordoma: a single-arm, single-centre, phase 2 study. Lancet Oncol. 2020 Sep;21(9):1244-1252. doi: 10.1016/S1470-2045(20)30466-6.
PubMed 32888455Chen Y, Jia Y, Liu Q, Shen Y, Zhu H, Dong X, Huang J, Lu J, Yin Q. Myocarditis related to immune checkpoint inhibitors treatment: two case reports and literature review. Ann Palliat Med. 2021 Jul;10(7):8512-8517. doi: 10.21037/apm-20-2620. Epub 2021 Jul 1.
PubMed 34263614Ulici V, Hart J. Chordoma. Arch Pathol Lab Med. 2022 Mar 1;146(3):386-395. doi: 10.5858/arpa.2020-0258-RA.
PubMed 34319396DeMaria PJ, Lee-Wisdom K, Donahue RN, Madan RA, Karzai F, Schwab A, Palena C, Jochems C, Floudas C, Strauss J, Marte JL, Redman JM, Dombi E, Widemann B, Korchin B, Adams T, Pico-Navarro C, Heery C, Schlom J, Gulley JL, Bilusic M. Phase 1 open-label trial of intravenous administration of MVA-BN-brachyury-TRICOM vaccine in patients with advanced cancer. J Immunother Cancer. 2021 Sep;9(9):e003238. doi: 10.1136/jitc-2021-003238.
PubMed 34479925Blay JY, Chevret S, Le Cesne A, Brahmi M, Penel N, Cousin S, Bertucci F, Bompas E, Ryckewaert T, Soibinet P, Boudou-Rouquette P, Saada Bouzid E, Soulie P, Valentin T, Lotz JP, Tosi D, Neviere Z, Cancel M, Ray-Coquard I, Gambotti L, Legrand F, Lamrani-Ghaouti A, Simon C, Even C, Massard C. Pembrolizumab in patients with rare and ultra-rare sarcomas (AcSe Pembrolizumab): analysis of a subgroup from a non-randomised, open-label, phase 2, basket trial. Lancet Oncol. 2023 Aug;24(8):892-902. doi: 10.1016/S1470-2045(23)00282-6. Epub 2023 Jul 7.
PubMed 37429302
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Phase 2 Study of Apatinib (Anti-PD-1) Combined With Camrelizumab (Anti-VEGFR ) in Patients With Advanced Chordoma
- ClinicalTrials.gov ID
- NCT06140732
- Acronym / sponsor ID
- XW-NS-ACCFC
- Conditions
- Chordoma, Chemotherapy Effect
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 20 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- camrelizumab 200 mg iv/ q2w+ apatinib 375mg oral qd
| Arm | Type | Receives |
|---|---|---|
| camrelizumab combined with apatinib | Experimental | Drug: camrelizumab and apatinibcamrelizumab 200 mg iv/ q2w+ apatinib 375mg oral qd |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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) :
- Biochemical examination shall meet the following standards:
Key exclusion criteria (17 listed)
- Except for those subjects whose toxicity had not recovered from previous antitumor therapy (concurrent chemoradiotherapy, surgical treatment) (alopecia, alkaline phosphatase, glutamine detranspeptase (GGT)) or who could be enrolled after discussion with the investigator and sponsor
- Use of immunosuppressive drugs within 14 days prior to first use of carrilizumab, excluding nasal and inhaled corticosteroids or systemic steroid hormones at physiological doses (i.e., no more than 10 mg/ day of prednisolone or other corticosteroids at pharmacologically equivalent doses);
- Previous treatment with anti-PD-1, anti-PD-L1, anti-VEGFR antibodies or anti-PD-L2 drugs or drugs that target another stimulus or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);
- Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg, despite systematic medication);
- Severe cardiovascular disease: Grade II or above myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval ≥450 ms for men and ≥470 ms for women); Grade Ⅲ to Ⅳ cardiac insufficiency (according to the New York Heart Society NYHA classification, see Annex 3), or left ventricular ejection fraction (LVEF) < 50% indicated by cardiac color ultrasound;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| camrelizumab and apatinibAlso: Targeted therapycamrelizumab 200 mg iv/ q2w+ apatinib 375mg oral qd | Drug | camrelizumab combined with apatinib |
Primary outcome
Effectiveness: Progression-free survival (PFS)
Time frame: 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
Time frame: 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.
3 secondary outcomes
Overall survival (OS), , disease
Time frame: From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year).
Objective response rate (OPR)
Time frame: From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year).
Control rate (DCR)
Time frame: From date of start treatment until date of first documented of progression of withdrawal (through study completion, an average of 1 year).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2023.
- Background: PubMed 35934010Somaiah N, Conley AP, Parra ER, Lin H, Amini B, Solis Soto L, Salazar R, Barreto C, Chen H, Gite S, Haymaker C, Nassif EF, Bernatchez C, Mitra A, Livingston JA, Ravi V, Araujo DM, Benjamin R, Patel S, Zarzour MA, Sabir S, Lazar AJ, Wang WL, Daw NC, Zhou X, Roland CL, Cooper ZA, Rodriguez-Canales J, Futreal A, Soria JC, Wistuba II, Hwu P. Durvalumab plus tremelimumab in advanced or metastatic soft tissue and bone sarcomas: a single-centre phase 2 trial. Lancet Oncol. 2022 Sep;23(9):1156-1166. doi: 10.1016/S1470-2045(22)00392-8. Epub 2022 Aug 4.
- Background: PubMed 32888455Liu C, Jia Q, Wei H, Yang X, Liu T, Zhao J, Ling Y, Wang C, Yu H, Li Z, Jiao J, Wu Z, Yang C, Xiao J. Apatinib in patients with advanced chordoma: a single-arm, single-centre, phase 2 study. Lancet Oncol. 2020 Sep;21(9):1244-1252. doi: 10.1016/S1470-2045(20)30466-6.
- Background: PubMed 34263614Chen Y, Jia Y, Liu Q, Shen Y, Zhu H, Dong X, Huang J, Lu J, Yin Q. Myocarditis related to immune checkpoint inhibitors treatment: two case reports and literature review. Ann Palliat Med. 2021 Jul;10(7):8512-8517. doi: 10.21037/apm-20-2620. Epub 2021 Jul 1.
- Background: PubMed 34319396Ulici V, Hart J. Chordoma. Arch Pathol Lab Med. 2022 Mar 1;146(3):386-395. doi: 10.5858/arpa.2020-0258-RA.
- Background: PubMed 34479925DeMaria PJ, Lee-Wisdom K, Donahue RN, Madan RA, Karzai F, Schwab A, Palena C, Jochems C, Floudas C, Strauss J, Marte JL, Redman JM, Dombi E, Widemann B, Korchin B, Adams T, Pico-Navarro C, Heery C, Schlom J, Gulley JL, Bilusic M. Phase 1 open-label trial of intravenous administration of MVA-BN-brachyury-TRICOM vaccine in patients with advanced cancer. J Immunother Cancer. 2021 Sep;9(9):e003238. doi: 10.1136/jitc-2021-003238.
- Results publication: PubMed 37429302Blay JY, Chevret S, Le Cesne A, Brahmi M, Penel N, Cousin S, Bertucci F, Bompas E, Ryckewaert T, Soibinet P, Boudou-Rouquette P, Saada Bouzid E, Soulie P, Valentin T, Lotz JP, Tosi D, Neviere Z, Cancel M, Ray-Coquard I, Gambotti L, Legrand F, Lamrani-Ghaouti A, Simon C, Even C, Massard C. Pembrolizumab in patients with rare and ultra-rare sarcomas (AcSe Pembrolizumab): analysis of a subgroup from a non-randomised, open-label, phase 2, basket trial. Lancet Oncol. 2023 Aug;24(8):892-902. doi: 10.1016/S1470-2045(23)00282-6. Epub 2023 Jul 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zan Chen principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing camrelizumab and apatinib in people with Chordoma and Chemotherapy Effect, run by Xuanwu Hospital, Beijing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zan Chen, Dr. (18131166269, qimaoyang777@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: Progression-free survival (PFS) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06140732, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2023.