Condition

Gallbladder and biliary tract cancer

Clinical trials and treatment information for Gallbladder and biliary tract cancer

314K
People Affected
80
Active Trials
173K
New Cases/Year
172K
Deaths/Year

Treatment Rankings

Ranked by evidence volume first. Medicine has spent centuries ranking things by vibes. This is an improvement.

1
Surgical Resection
85% Effectivenessβ€’ 95% Confidenceβ€’ 35% Safetyβ€’ 22 trialsβ€’ 5M participants
HIGH EvidenceExcellent Value
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Comparative Safety Scale(Higher is safer)

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35
DangerousModerateSafe

Time to Effect

immediate

Duration

1-3 months recovery, lifelong follow-up

Response Rate

%

Remission Rate

40%

Common Side Effects:

Pain: 90%
Infection: 15%
Bleeding: 7%
Anastomotic leak (if bile duct resection): 10%
Pancreatitis (for Whipple): 15%
Bile leak: 10%

Annual Cost of Care

Drug Cost

$0

Monitoring

$10,000

Side Effects

$15,000

Total Annual

$125,000

Cost-Effectiveness

EXCELLENT

QALYs Gained

2

Cost per Remission

$312,500

Treatment Outcomes
Primary Outcomes
Median Overall Survival6 months (for advanced unresectable disease)
+400% (+24 months)
Median Disease-Free Survival3 months (for advanced unresectable disease where progression is imminent)
+566.67% (+17 months)
2-Year Local Recurrence Rate70% (in patients with unresected or R1/R2 disease)
-71.43% (-50 percentage points)
Total Bilirubin10 mg/dL (severe obstructive jaundice)
-85% (-8.5 mg/dL)
Secondary Benefits
Pain Intensity (NRS 0-10)7/10 (moderate-severe cancer pain)
-71.43% (-5 points)
Global Health Status / QoL Score (EORTC QLQ-C30, 0-100)30/100 (poor quality of life due to cancer symptoms)
+100% (+30 points)
ECOG Performance Status (0-5 scale)2 (symptomatic, in bed <50% of time)
-50% (-1 point)
Common Side Effects
Pain
+90%
Infection
+15%
Bleeding
+7%

Clinical Trial Phases:

Phase 4
2
Durvalumab + Gemcitabine/Cisplatin
60% Effectivenessβ€’ 90% Confidenceβ€’ 28% Safetyβ€’ 5 trialsβ€’ 10K participants
HIGH EvidencePoor ValueDose: Durvalumab 1500mg IV every 3 weeks (with GemCis for 8 cycles, then monotherapy)
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Comparative Safety Scale(Higher is safer)

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28
DangerousModerateSafe

Time to Effect

1-3 months

Duration

Until progression or unacceptable toxicity (6-18+ months)

Response Rate

27%

Remission Rate

3%

Number Needed to Treat (NNT)

12

Common Side Effects:

Myelosuppression: 55%
Fatigue: 60%
Nausea/Vomiting: 40%
Peripheral neuropathy: 30%
Immune-related adverse events: 10%

Annual Cost of Care

Drug Cost

$130,000

Monitoring

$20,000

Side Effects

$15,000

Total Annual

$165,000

Cost-Effectiveness

POOR

QALYs Gained

0.9

ICER

$300,000/QALY

Cost per Remission

$5,500,000

Cost per Responder

$611,111

Treatment Outcomes
Primary Outcomes
Overall SurvivalMedian OS with chemotherapy alone: 11.5 months
+11.3% (+1.3 months)
Progression-Free SurvivalMedian PFS with chemotherapy alone: 5.7 months
+26.3% (+1.5 months)
Objective Response Rate (ORR)ORR with chemotherapy alone: 18.7%
+43.8% (+8.2 percentage points (26.9% vs 18.7%))
Disease Control Rate (DCR)DCR with chemotherapy alone: 71.4%
+13.9% (+9.9 percentage points (81.3% vs 71.4%))
Secondary Benefits
CA19-9 LevelsTypical elevated baseline: 200 U/mL
-30% (-60 U/mL)
Time to Definitive Deterioration of Global Health Status/QoL (EORTC QLQ-C30)Median TTD with chemotherapy alone: 5.0 months
+30% (+1.5 months)
Common Side Effects
Myelosuppression
+55%
Fatigue
+60%
Nausea/Vomiting
+40%

Clinical Trial Phases:

Phase 3Phase 4
3
Gemcitabine + Cisplatin
55% Effectivenessβ€’ 90% Confidenceβ€’ 25% Safetyβ€’ 41 trialsβ€’ 20K participants
HIGH EvidenceGood ValueDose: Gemcitabine 1000 mg/mΒ² IV (day 1, 8) + Cisplatin 25 mg/mΒ² IV (day 1) every 21 days
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Comparative Safety Scale(Higher is safer)

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25
DangerousModerateSafe

Time to Effect

1-2 months

Duration

Typically 6-8 cycles (4-6 months)

Response Rate

25%

Remission Rate

2%

Number Needed to Treat (NNT)

8

Number Needed to Harm (NNH)

4

Common Side Effects:

Myelosuppression: 60%
Fatigue: 60%
Nausea/Vomiting: 40%
Peripheral neuropathy: 30%
Nephrotoxicity: 15%

Annual Cost of Care

Drug Cost

$10,000

Monitoring

$20,000

Side Effects

$15,000

Total Annual

$45,000

Cost-Effectiveness

GOOD

QALYs Gained

0.7

ICER

$50,000/QALY

Cost per Remission

$2,250,000

Cost per Responder

$180,000

Treatment Outcomes
Primary Outcomes
Overall Survival (median)8.1 months (for Gemcitabine monotherapy)
+44.4% (+3.6 months)
Progression-Free Survival (median)5.0 months (for Gemcitabine monotherapy)
+60% (+3.0 months)
Overall Response Rate (ORR)15% (for Gemcitabine monotherapy)
+73.3% (+11 percentage points)
Secondary Benefits
Disease Control Rate (DCR)50% (for Gemcitabine monotherapy)
+62% (+31 percentage points)
CA 19-9 Levels1000 U/mL
-70% (-700 U/mL)
Pain Score (BPI-SF Worst Pain)6/10 (on numeric rating scale)
-33% (-2 points)
Common Side Effects
Myelosuppression
+60%
Fatigue
+60%
Nausea/Vomiting
+40%

Clinical Trial Phases:

Phase 3Phase 4
4
Pemigatinib (FGFR2 Inhibitor)
50% Effectivenessβ€’ 80% Confidenceβ€’ 40% Safetyβ€’ 30 trialsβ€’ 500 participants
MODERATE EvidencePoor ValueDose: 13.5 mg orally once daily for 14 consecutive days followed by 7 days off
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Comparative Safety Scale(Higher is safer)

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40
DangerousModerateSafe

Time to Effect

1-3 months

Duration

Until progression or unacceptable toxicity (6-18+ months)

Response Rate

36%

Remission Rate

3%

Common Side Effects:

Hyperphosphatemia: 70%
Alopecia: 45%
Diarrhea: 35%
Fatigue: 35%
Nail toxicity: 25%

Annual Cost of Care

Drug Cost

$200,000

Monitoring

$15,000

Side Effects

$10,000

Total Annual

$225,000

Cost-Effectiveness

POOR

QALYs Gained

0.7

ICER

$400,000/QALY

Cost per Remission

$7,500,000

Cost per Responder

$625,000

Treatment Outcomes
Efficacy Outcomes
Overall Effectiveness
+50%
Response Rate
+36%
Remission Rate
+3%
Common Side Effects
Hyperphosphatemia
+70%
Alopecia
+45%
Diarrhea
+35%

Clinical Trial Phases:

Phase 2Phase 3
5
Ivosidenib (IDH1 Inhibitor)
40% Effectivenessβ€’ 75% Confidenceβ€’ 45% Safetyβ€’ 20 trialsβ€’ 300 participants
MODERATE EvidencePoor ValueDose: 500 mg orally once daily
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Comparative Safety Scale(Higher is safer)

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45
DangerousModerateSafe

Time to Effect

2-4 months

Duration

Until progression or unacceptable toxicity (6-18+ months)

Response Rate

2%

Remission Rate

0.5%

Common Side Effects:

Nausea: 35%
Fatigue: 35%
Diarrhea: 30%
Abdominal pain: 25%
QTc prolongation: 12%

Annual Cost of Care

Drug Cost

$270,000

Monitoring

$15,000

Side Effects

$5,000

Total Annual

$290,000

Cost-Effectiveness

POOR

QALYs Gained

0.2

ICER

$900,000/QALY

Cost per Remission

$58,000,000

Cost per Responder

$14,500,000

Treatment Outcomes
Efficacy Outcomes
Overall Effectiveness
+40%
Response Rate
+2%
Remission Rate
+0.5%
Common Side Effects
Nausea
+35%
Fatigue
+35%
Diarrhea
+30%

Clinical Trial Phases:

Phase 3
6
Radiation Therapy (Adjuvant/Palliative)
35% Effectivenessβ€’ 85% Confidenceβ€’ 25% Safetyβ€’ 500 trialsβ€’ 50K participants
MODERATE EvidenceModerate ValueDose: 45-60 Gy in 1.8-2 Gy fractions (definitive/adjuvant); 20-30 Gy in 5-10 fractions (palliative)
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Comparative Safety Scale(Higher is safer)

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25
DangerousModerateSafe

Time to Effect

Weeks to months for tumor control, immediate to weeks for symptom relief

Duration

3-6 weeks (adjuvant/definitive), 1-2 weeks (palliative)

Response Rate

20%

Remission Rate

0.5%

Common Side Effects:

Fatigue: 60%
Skin irritation/Dermatitis: 50%
Nausea/Vomiting (if abdominal): 40%
Diarrhea (if abdominal): 30%
Myelosuppression: 20%

Annual Cost of Care

Drug Cost

$0

Monitoring

$15,000

Side Effects

$10,000

Total Annual

$60,000

Cost-Effectiveness

MODERATE

QALYs Gained

0.2

ICER

$100,000/QALY

Cost per Remission

$12,000,000

Cost per Responder

$300,000

Treatment Outcomes
Efficacy Outcomes
Overall Effectiveness
+35%
Response Rate
+20%
Remission Rate
+0.5%
Common Side Effects
Fatigue
+60%
Skin irritation/Dermatitis
+50%
Nausea/Vomiting (if abdominal)
+40%

Clinical Trial Phases:

Phase 3Phase 4