NCT06171321

Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma

Circulating Tumor DNA Guided Adjuvant Chemotherapy for Biliary Tract Carcinoma: A Prospective Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: Shanghai East Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In recent years, circulating tumor DNA (ctDNA)had achieved encouraging results in monitoring recurrence and metastasis after surgery, and has potential clinical application value. The presence of ctDNA after surgery predicts very poor recurrence-free survival, whereas its absence predicts a low risk of recurrence. The benefit of adjuvant chemotherapy for ctDNA-positive patients is not well understood.

Detailed description

The results of the PRODIGE-12/ACCORD-18 study showed that, with a median follow-up of 47 months, the adjuvant chemotherapy arm did not lead to a significant improvement in recurrence-free survival (RFS) and overall survival (OS). Notably, the patients with gallbladder cancer experienced adjuvant chemotherapy significantly worse RFS and OS compared to those in the monitoring arm. ctDNA risk stratifies patients to guide adjuvant treatment decisions This study aimed to demonstrate that a escalation strategy of ctDNA guided adjuvant chemotherapy is superior to standard of care treatment as measured by 2 year disease free survival (DFS) in patients with stage II- III biliary tract cancers with minimal residual disease (MRD) (ctDNA positive).

Conditions

• Biliary Tract Cancer

Interventions

Type	Name	Description
DRUG	S-1(Intravenous combined with oral)	Oral combined with intravenous S-1 for ctDNA-positive patients (escalating treatment strategy)

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-11-15
• Completion: 2026-04-01
• First posted: 2023-12-14
• Last updated: 2023-12-14

Locations

1 site across 1 country: China