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An observational clinical study of the safety and efficacy of surufatinib in advanced solid tumors

An observational clinical study of the safety and efficacy of surufatinib in advanced solid tumors

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084499
Enrollment
Unknown
Registered
2024-05-17
Start date
2024-05-25
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

Solid tumor

Interventions

Test group:Surufatinib ± chemotherapy ± IO

Sponsors

Fengxian People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age =18 years old, both sexes, volunteer to participate in the trial and sign informed consent; 2. Advanced solid tumors confirmed by pathology; Including non-small cell lung cancer, small cell lung cancer, esophageal cancer, gastric cancer (including gastroesophageal junction adenocarcinoma), colorectal cancer, biliary tract cancer, liver/pancreatic cancer, etc. 3. Patients who failed or could not tolerate standard treatment; 4.ECOG score: 0-3; 5. At least one CT measurable lesion according to RECIST 1.1 criteria; 6. Expected survival for at least 3 months. 7. Investigator assessment of benefit; 8. All subjects voluntarily participated in the study and signed the informed consent form (ICF); 9. Good compliance is expected, and the efficacy and adverse reactions can be followed up according to the protocol.

Exclusion criteria

Exclusion criteria: 1. Patients allergic to surufatinib; 2. Patients with severe allergic history or allergic constitution; 3. Pregnant or lactating women; 4. Subjects with dysphagia or known drug malabsorption; 5. Patients who have participated in other clinical trials and have not discontinued the trial; 6. Major surgical treatment, open biopsy, or significant traumatic injury within 28 days before grouping (combined with clinical assessment); 7. Patients whose imaging showed that the tumor had invaded the important blood vessels or the investigator judged that the tumor was likely to invade the important blood vessels during the follow-up study, causing fatal hemorrhage; 8. Patients with any constitutional sign or history of bleeding regardless of severity; Patients with unhealed wounds, ulcers, or fractures who experienced any bleeding or bleeding event =CTCAE grade 3 within 4 weeks before enrollment; Patients with previous arterial/venous thrombosis events within 9.6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism; 10. Have a history of psychotropic drug abuse and cannot quit or have mental disorders; 11. Other conditions considered by the investigator to be inappropriate for enrollment.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival;

Secondary

MeasureTime frame
Overall Survival;Objective Response Rate;Disease Control Rate;

Countries

China

Contacts

Public ContactXiuping Du

Fengxian People's Hospital

908512336@qq.com+86 180 5226 8229

Outcome results

None listed

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