Colorectal cancer
Conditions
Interventions
Monotherapy with targeted drugs ± immunotherapy group:None
Chemotherapy plus targeted therapy group:None
Chemotherapy alone group:None
Sponsors
Peking University International Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years; no restrictions on sex or gender; 2. Histopathologically confirmed colorectal adenocarcinoma; 3. Proficient mismatch repair/microsatellite stable (pMMR/MSS) status confirmed by immunohistochemistry (IHC) and/or polymerase chain reaction (PCR); 4. Radiologically confirmed liver and/or lung metastases—either initially unresectable or rendered resectable following conversion therapy; 5. Completion of >= 4 months of first-line induction therapy (chemotherapy with or without targeted agents), achieving disease control defined as stable disease (SD), partial response (PR), or complete response (CR) per RECIST v1.1 criteria; 6. Receipt of >= 2 months of maintenance therapy, including fluoropyrimidine-based regimens (monotherapy or combined with targeted agents), immune checkpoint inhibitors, or anti-angiogenic agents; 7. Availability of complete baseline clinical, imaging, and laboratory data, as well as longitudinal follow-up records sufficient for progression-free survival (PFS) assessment.
Exclusion criteria
Exclusion criteria: 1. Microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) colorectal cancer; 2. Concurrent active malignancy other than non-melanoma skin cancer; 3. Leptomeningeal carcinomatosis or radiologically confirmed active brain metastases; 4. Receipt of locoregional interventions—including surgery, radiofrequency ablation, or radiotherapy—during the maintenance therapy period; 5. Incomplete baseline clinical, imaging, or laboratory data, or loss to follow-up prior to primary endpoint assessment; 6. Treatment interruption exceeding two months during maintenance therapy for reasons unrelated to disease progression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival;Disease control rate;Time to treatment failure; | — |
Countries
China
Contacts
Public ContactDongdong Zhang
Peking University International Hospital
Outcome results
None listed