Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07509398 | FMT Combined With Standard First-Line Therapy in Initially Unresectable Colorectal Cancer | PHASE2 | NOT YET_RECRUITING | 220 | — | — | Apr 1, 2026 | Dec 1, 2031 | Apr 3, 2026 | - | — |
| Arm | Type | Description |
|---|---|---|
| Standard First-Line Therapy | ACTIVE_COMPARATOR | Patients receive investigator's choice of standard first-line systemic therapy for initially unresectable colorectal cancer (e.g., chemotherapy ± targeted therapy or anti-angiogenic agents according to CSCO/NCCN guidelines and RAS status). |
| FMT Combined with Standard First-Line Therapy | EXPERIMENTAL | Patients receive fecal microbiota transplantation (FMT) in addition to the same standard first-line systemic therapy as in the control arm. FMT is administered according to the study protocol (donor-screened, prepared under GMP/P2 conditions, capsule delivery). |
| Name | Type | Description |
|---|---|---|
| Standard First-Line Therapy | DRUG | Investigator's choice of standard first-line systemic therapy for initially unresectable colorectal cancer, including chemotherapy (e.g., FOLFOX, FOLFIRI, CAPOX) with or without targeted therapy or anti-angiogenic agents (e.g., cetuximab, panitumumab for RAS wild-type; bevacizumab for others), according to CSCO/NCCN guidelines and RAS mutation status. |
| FMT Combined with Standard First-Line Therapy | COMBINATION_PRODUCT | Fecal microbiota transplantation using donor stool from healthy screened donors. Prepared under P2/GMP conditions as capsules or suspension. Administered in addition to standard therapy per study protocol (induction phase followed by maintenance). |
Inclusion Criteria: * (1) Subjects must volunteer to participate in this study, sign the informed consent form (ICF), and demonstrate good compliance. (2) Patients aged 18 to 75 years (inclusive). (3) Meet the defined criteria for initially unresectable advanced metastatic colorectal cancer (mCR...