Circulating tumor DNA directed additional imaging and treatment in stage IV colorectal cancer after completion of planned curative treatment (CLAUDIA-IV)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0012144

Enrollment

271

Registered

2026-06-17

Start date

2026-09-01

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

None listed

Interventions

Drug : Platform trial. Of 271 enrollees, only ctDNA-positive and imaging-negative participants (~26) receive investigational drug in Part 2. Others undergo imaging evaluation (Part 1) or surveillance

re-entry is permitted after completion. Part 2 (CLAUDIA Treatment) — Investigational drug administration Participants who are ctDNA-positive and imaging-negative in Part 1 receive: Telisotuzumab adi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: **Inclusion Criteria:** • Age = 19 years • ECOG Performance Status 0–1 • Pathologically confirmed stage IV colorectal cancer with curative resection (Note: non-surgical curative treatments such as RFA, SBRT/SABR, TACE, or TARE are not considered curative resection) • Complete resection (post-R0 resection) • Completion of planned postoperative adjuvant therapy (chemotherapy or chemoradiotherapy) with only surveillance planned thereafter (patients with no planned adjuvant therapy after resection are also eligible) • No radiological evidence of metastasis on CT (chest and abdomen) performed within 4 weeks prior to study enrollment • Last administration of adjuvant chemotherapy = 4 weeks and = 12 months prior to study enrollment • Medically fit to undergo additional local treatment including surgery • Signed written informed consent (ICF) prior to any study procedures

Exclusion criteria

Exclusion criteria: **Exclusion Criteria:** • Incomplete resection (R1 or R2) • Major surgery within 4 weeks prior to study enrollment • Liver MRI or FDG-PET performed within 3 months prior to study enrollment • Known contraindication to any of the contrast agents used in the study • Significant renal impairment (creatinine clearance < 30 mL/min by Cockcroft-Gault formula after hydration, or requiring dialysis) • Prior treatment with MET-targeted agents (applicable to Part 2 Telisotuzumab adizutecan + Bevacizumab cohort) • Known contraindication to Bevacizumab (applicable to Part 2 Telisotuzumab adizutecan + Bevacizumab cohort)

Design outcomes

Primary

Measure	Time frame
Part 1: Rate of residual disease detection by additional imaging (Liver MRI and FDG-PET) among ctDNA-positive patients/ Part 2: Disease-Free Survival at 12 months (1-year DFS)	—

Secondary

Measure	Time frame
Event-Free Survival, EFS;ctDNA clearance rate;Incidence and severity of adverse events (per NCI-CTCAE v5.0)	—

Countries

Korea, Republic of

Contacts

Public ContactYuri Park

Seoul National University Hospital

yuripark@snu.ac.kr+82-2-3668-7087

Outcome results