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A real-world study of fruquintinib in the cross-line treatment of metastatic colorectal cancer

Continuation of Fruquintinib after progression in metastatic colorectal cancer: a real-world study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400082593
Enrollment
Unknown
Registered
2024-04-01
Start date
2024-04-01
Completion date
Unknown
Last updated
2024-04-08

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

Conditions

Colorectal cancer

Interventions

Corhot 1: second-line cross to third-line:None
Corhot 2: third-line cross to fourth-line:None

Sponsors

Xiantao First People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: To be enrolled in this study, patients must meet all of the following criteria: Corhot 1: second-line cross to third-line 1. Age =18 years and =75 years; 2. No gender limitation; 3. Patients with metastatic colorectal cancer confirmed by histopathology had previously received first-line treatment with bevacizumab combined with standard chemotherapy, and second-line treatment with fruquintinib combined with standard chemotherapy. After progression , fruquintinib combined with PD-1 inhibitors and chemotherapy had been received as third-line treatment. 4. Fruquintinib was received at least one cycle after crossing to the third-line. 5. Imaging assessment of tumors was done at least once after crossing to the third-line. 6. ECOG PS 0-1 before crossing to the third-line. Corhot 2: third-line cross to fourth-line 1. Age =18 years and =75 years; 2. No gender limitation; 3. Patients with metastatic colorectal cancer confirmed by histopathology had previously received two lines system therapy which included fluorouracil, oxaliplatin, irinotecan, anti-VEGF, anti-EGFR (RAS and BRAF wild type) (treatment with anti-VEGF-TKI is not allowed), and had received fruquintinib-based regimens as third-line treatment, and had continued fruquintinib-based regimens as fourth-line treatment after progression. 4. Fruquintinib was received at least one cycle after crossing to the fourth-line. 5. Imaging assessment of tumors was done at least once after crossing to the fourth-line. 6. ECOG PS 0-1 before crossing to the fourth-line.

Exclusion criteria

Exclusion criteria: Patients will not be admitted to the study if they meet any of the following criteria: Corhot 1: second-line cross to third-line 1. Patients with contraindications to study drugs (fruquintinib, PD-1 inhibitors, chemotherapy drugs); 2. Allergic to the investigational drug or any of its adjuncts; 3. There are other non-investigational drugs during second-line and third-line treatment 4. Pregnant or lactating female subjects; 5. Patients with a large number of pleural effusion or ascites requiring drainage; 6. No tumor efficacy evaluation was performed after treatment with fruquintinib 7. Patients whose follow-up information was insufficient for analysis determined by the investigator (e.g., No more visits to the hospital for treatment or evaluation after initial treatment) Corhot 2: third-line cross to fourth-line 1. Patients with contraindications to study drugs (fruquintinib, PD-1 inhibitors, chemotherapy drugs); 2. Allergic to the investigational drug or any of its adjuncts; 3. There are other non-investigational drugs during third-line and fourth-line treatment 4. Pregnant or lactating female subjects; 5. Patients with a large number of pleural effusion or ascites requiring drainage; 6. No tumor efficacy evaluation was performed after treatment with fruquintinib 7. Patients whose follow-up information was insufficient for analysis determined by the investigator (e.g., No more visits to the hospital for treatment or evaluation after initial treatment)

Design outcomes

Primary

MeasureTime frame
Progression-free survival(PFS);Overall survival(OS);

Secondary

MeasureTime frame
Objective Response Rate(ORR);Disease control rate(DCR);

Countries

China

Contacts

Public ContactLiPing Li

Xiantao First People's Hospital

13477410999@163.com+86 134 7741 0999

Outcome results

None listed

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