Evaluating efficacy of S1 Oxaliplatin in patinets of unresectabe biliary tract malignancies with hyperbilirubinemia

EVALUATING THE EFFICACY AND SAFETY OF S1 OXALIPLATIN IN PATIENTS OF UNRESECTABLE AND METASTATIC BILIARY TRACT MALIGNANCIES WITH HYPERBILIRUBINEMIA - A PHASE II TRIAL - SOX GB

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/04/108053

Enrollment

Registered

2026-04-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: C23- Malignant neoplasm of gallbladder

Interventions

Intervention1: S1 Oxaliplatin: S1 tablet 20 mg/m2,twice daily, 14 days on and 7 days off, Inj Oxaliplatin 85 mg/m2 on day 1

assess disease response at 3 months Control Intervention1: Nil: NIl

Eligibility

Inclusion criteria

Inclusion criteria: 18 -75 years, hyperbilirubinemia post biliary draiange (3.75) in histologically/cytologically confirmed biliary tract malignancy

Exclusion criteria

Exclusion criteria: ECOG PS greater than or equal to 3, severe uncontrolled neuropathy, knowns cns disease, prior chemotherapy

Design outcomes

Primary

Measure	Time frame
Disease control rateTimepoint: 12 weeks from the start of chemotherapy	—

Secondary

Measure	Time frame
Progression free survivalTimepoint: 6 months;Rate of fall of bilirubin and CA 19.9Timepoint: 3 months;Note the toxicity profile of S1 and oxaliplatinTimepoint: 3 months	—

Countries

India

Contacts

Public ContactKoneti Harshith Sai

PGIMER, Chandigarh

drgp04@gmail.com9914209678

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026