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Safety and efficacy of anlotinib combined with TQB2450 in the treatment of advanced chordoma: a single-arm, prospective, phase II clinical trial

Safety and efficacy of anlotinib combined with TQB2450 in the treatment of advanced chordoma: a single-arm, prospective, phase II clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068998
Enrollment
Unknown
Registered
2023-03-03
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-05-22

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

Conditions

chordoma

Interventions

Experimental Group:Anlotinib (Forcovi , 10mg, d1-14 per cycle, po)
TQB2450 (1200 mg on day 1 per cycle, iv). Every 21 days (3 weeks) was a cycle. Until disease progression or intolerable toxicity.

Sponsors

Shanghai General Hospital, Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients with histologically confirmed chordoma who underwent X-ray, CT or magnetic resonance imaging; 2. VEGFR/PDGFR/FGFR+ and PD-L1+ confirmed by immunohistochemistry (TC (VEGFR/PDGFR/FGFR) score >=50% and CPS (PD-L1) score >=1); 3. Patients with proven advanced chordoma who cannot benefit from surgery or radiotherapy; 4. Good functional status (hemoglobin >=9 g/dL) and ECOG performance status 0-1; 5. The expected survival time is more than 6 months; 6. Measurable lesions (RECIST 1.1); 7. Aged 18-75 years.

Exclusion criteria

Exclusion criteria: 1. A history of severe mental illness, such as bipolar disorder or mental illness, that can affect clinical assessment parameters; 2. Patients who have received other multi-target anti-angiogenic drugs and/or immunotherapy in the past, or who are allergic to the active ingredients and excipients of relevant therapeutic drugs; 3. The patient failed to follow up for at least 6 months as instructed by the doctor; 4. Currently participating in an interventional clinical study, or receiving other investigational drugs or using investigational devices within 4 weeks prior to initial dosing; 5. Received major surgical treatment (except surgery for biopsy) within 2-4 weeks of drug administration in the first study; 6. Multiple factors affecting oral medication (such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction); 7. Other groups not suitable to participate in intervention studies, such as pregnant patients, patients with multiple tumors, and patients with severe liver and kidney dysfunction who cannot tolerate treatment.

Design outcomes

Primary

MeasureTime frame
objective remission rate;

Secondary

MeasureTime frame
progression free survival;disease control rate;overall survival;symptoms and living conditions;assessments of safety;

Countries

China

Contacts

Public ContactMeng Tong

Shanghai General Hospital, Shanghai Jiaotong University

mengtong@medmail.com.cn+86 13764235009

Outcome results

None listed

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