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A prospective, open, single-center, single-arm phase II clinical study of PD-1 inhibitor combined with Furquintinib or Regominib in the treatment of third-line and later advanced colorectal cancer patients

A prospective, open, single-center, single-arm phase II clinical study of PD-1 inhibitor combined with Furquintinib or Regominib in the treatment of third-line and later advanced colorectal cancer patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037752
Enrollment
Unknown
Registered
2020-08-31
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-11-02

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

Conditions

colorectal cancer

Interventions

Case series:PD-1 inhibitor combined with Furquintinib or Regominib

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Participated in the study voluntarily and signed the written informed consent; (2) Aged 18-75 year old male or female; (3) Subjects histologically diagnosed with colorectal cancer and who have failed first-line and second-line treatment regimes; (4) Subjects must have measurable target lesions examined by CT or MRI according to RECIST1.1 criteria. Imaging evaluation of the tumor was performed within 28 days prior to the first administration; (5) Estimated survival time >=3 months; (6) The physical condition ECOG status score 0-1; (7) Adequate function of vital organs (hematology, liver and kidney functions, etc.). These include adequate organ functions as follows: Bone marrow: Absolute value of neutrophils (ANC)>=1.5*109/L; Platelet >=100*109/L, hemoglobin >=9g/L. Liver function: bilirubin =1.5 times the upper limit of normal value (ULN); Alkaline phosphatase (AP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) =3 times ULN(if liver metastasis occurs, AP,ALT,AST =5 times ULN). Renal function: creatinine clearance =45mL/min(standard Cockcroft-Gault formula) (8) Asymptomatic brain metastasis and no spinal cord compression

Exclusion criteria

Exclusion criteria: (1) Radiotherapy or surgery was performed within 30 days before study treatment; (2) Previously, pD-1 /PD-L1 inhibitor monoclonal antibody was used to treat VEGF pathway targeting, EGFR pathway targeting or other signal transduction pathway inhibitors; (3) Spinal cord compression with active brain metastasis and carcinoma; (4) Obvious cavitation or necrosis within the tumor; (5) Poor control of infection; (6) Poor control of serous cavity effusion; (7) A clear neurological or psychiatric history, including epilepsy or dementia; (8) Other exclusion criteria refer to standard clinical study requirements.

Design outcomes

Primary

MeasureTime frame
Effect and safety;—

Countries

China

Contacts

Public ContactSijia He

Shanghai General Hospital

he-si-jia@163.com+86 13917402248

Outcome results

None listed

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