Health TrialsbyHealthPanel

Investigating Precision Medicine in the Adjuvant Setting in Biliary Tract Cancer

ConditionBiliary Tract Cancer (BTC)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER

About this trial

The objective of SAFIR-IMPACT BTC is to see whether, combining or replacing the standard adjuvant chemotherapy with a targeted therapy matched to the person's cancer, is better than the standard treatment alone in delaying or preventing the return of the cancer.

Three different targeted therapies will be evaluated, each of which recognises a different type of abnormality in cancer cells:

* Ivosidenib - a drug which acts on a specific abnormality in a protein called IDH1. * Futibatinib - a drug which acts on abnormalities in a protein called FGFR2 * Zanidatamab - a drug which acts on cancers that produce more than the usual quantity of a protein called HER2.

The trial is composed of two phases:

(i) An initial screening phase to identify a suitable patient population, during which a sample of the patient's tumour will be tested to see if it has one of the target abnormalities being studied (ii) a randomised comparative phase (for selected patients only) which consists of comparing two treatment options: some patients will receive the targeted therapy specific to the abnormality identified in their tumour, while others will receive the standard treatment. Patients will be assigned to one treatment or the other by a random draw: they will have a 2 in 3 chance of receiving the targeted therapy.

Randomised participants will:

* Take their assigned treatment for 6 months * Visit the clinic once every 3 weeks for checkups and tests * Keep a diary of their symptoms and the treatment they take at home Follow-up information will be collected for all participants until the end of the trial.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed a written informed consent form prior to any trial specific procedures (Consent #1)

Histologically-proven intrahepatic cholangiocarcinoma, perihilar or distal extrahepatic cholangiocarcinoma or gallbladder carcinoma (ampullary carcinoma is excluded)

Macroscopically complete resection of the primary tumour (R0 or R1 surgical margin status)

Aged ≥18 years

Disqualifiers

Contraindication to standard adjuvant therapy

Prior anticancer therapy in the neoadjuvant or adjuvant setting.

Patients with gallbladder cancer which has not extended to involve the muscle layers or lymph nodes (pT1aN0)

Planned post-operative radiation therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Futibatinib

    Drug

    Dose 20 mg once a day (QD)

  • Ivosidenib + Capecitabine

    Drug

    Ivosidenib: Dose 500 mg QD Capecitabine: 1250mg/m² BID for 14 days on, 7 days off, in 3 week cycles

  • Zanidatamab + Capecitabine

    Drug

    Zanidatamab: Patients \< 70 kg: 1800 mg every 3 weeks (Q3W), Patients ≥ 70 kg: 2400 mg Q3W Capecitabine: 1250mg/m² BID for 14 days on, 7 days off, in 3 week cycles

  • Capecitabine (Xeloda)

    Drug

    1250mg/m² BID for 14 days on, 7 days off, in 3 week cycles

Treatment groups

990 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 3 interventions
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Relapse-free survival

Time from randomisation to the first documented relapse of disease, as assessed by the investigator, or death from any cause, whichever occurs first

Time frame
From randomisation to disease or death, up to 5 years

Secondary outcomes

1

Overall Survival

Time from randomisation to death due to any cause

Time frame
From randomisation to death, up to 5 years
2

Post-relapse survival

Time from documented relapse to death due to any cause

Time frame
From randomisation to death, up to 5 years
3

ctDNA-clearance

The proportion of patients achieving the transition from ctDNA positivity at inclusion to ctDNA negativity at 24 weeks

Time frame
From randomisation to 24 weeks
4

Time-to-ctDNA recurrence

Time from randomisation to the time of ctDNA positivation

Time frame
From randomisation, up to 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

UNICANCER

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: