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A phase II single arm study of sindilizumab in combination with furquinib and a third line treatment with temozolomide in patients with MSS metastatic colorectal cancer

A phase II, single arm study of sindilizumab in combination with furquinib and a third line treatment with temozolomide in patients with MSS metastatic colorectal cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079188
Enrollment
Unknown
Registered
2023-12-27
Start date
2022-06-22
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

MSS-type Advanced Colorectal Cancer

Interventions

Intervention group:Sindilizumab injection + furaquinib capsule + tegumentary capsule

Sponsors

Three department of internal medicine, College of traditional Chinese medicine, Guangdong, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: ? Patients with pathologically confirmed colorectal cancer, staged as stage IV patients; ? Colorectal cancer patients with histologically confirmed MSS; ? Patients with disease progression or resistance to at least two or more systemic chemotherapy regimens; ? Card style score (Karnofsky, KPS) = 60 points; ? Those with normal bone marrow, liver, kidney, heart, and lung function; ? Age between 18 and 80 years; ? Informed consent to participate in this study, with good compliance and those who could be followed up.

Exclusion criteria

Exclusion criteria: ? Had brain metastases, severe brain disease, or mental illness that affected the patient's ability to self-report; ? Those with comorbid active tuberculosis and other severe infectious diseases; ? Pregnant or lactating women; ? Those with severe allergic constitution.

Design outcomes

Primary

MeasureTime frame
Progression free survival;Incidence rate of adverse drug events;

Secondary

MeasureTime frame
Disease control rate;Overall survival;KPS score;

Countries

China

Contacts

Public ContactLi Liu-ning

Three department of internal medicine, College of traditional Chinese medicine, Guangdong, China

liliuning97@126.com+86 139 2509 2416

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026