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Clinical Trials/CTRI/2020/05/025147
CTRI/2020/05/025147
Recruiting
Phase 2

Comprehensive Genomic Profiling by Next Generation Sequencing (Foundation Medicine) Of Advanced Biliary Tract Cancers (Gallbladder, Cholangiocarcinoma) And Guided Treatment: A Phase 2, Prospective, Multicenter Study.

Armed Forces Medical Research Committee0 sites0 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Armed Forces Medical Research Committee
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Armed Forces Medical Research Committee

Eligibility Criteria

Inclusion Criteria

  • •Histologically proven cases of adenocarcinoma of gallbladder and Cholangiocarcinoma.
  • •Locally advanced, unresectable or metastatic disease
  • •ECOG Performance status \<2
  • •Adequate bone marrow function reflected
  • •Hemoglobin \> 8 gm/dl, TLC \> 4,000/cumm
  • •(ANC \>1,500/cumm), and Platelets \>1,00,000/cumm)
  • •Serum creatinine \<1\.8 mg%
  • •Serum bilirubin \< 3 mg%
  • •Liver enzymes (SGOT and SGPT) within 3 times the
  • •upper normal limit

Exclusion Criteria

  • •Women of reproductive age group not practicing
  • •contraception.
  • •Lactating and pregnant women.
  • •History of previous carcinoma in last 5 yrs.
  • •Active hepatitis B, C or HIV infection.

Outcomes

Primary Outcomes

Not specified

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