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A Randomized, Two-cohort, Prospective Phase II Clinical Study of the Second-line Treatment of Advanced Biliary System Tumors With Liposomal Irinotecan (II) Combination Regimen

ConditionBiliary Tract Cancer (BTC)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

This is a randomized, two-cohort, multicenter Phase II clinical study. To evaluate the efficacy and safety of liposomal irinotecan II and 5-FU/LV combined with or without renvastinib in the treatment of patients with advanced biliary system tumors, 90 patients were scheduled to be enrolled.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

The patients voluntarily joined the study and signed the informed consent;

Histologically or cell line confirmed advanced biliary system malignancies, including intrahepatic, extrahepatic, and gallbladder cancers;

Previous first-line combination therapy failed;

At least one measurable lesion meets the RECIST v1.1 criteria

Disqualifiers

The patient had previously received irinotecan, 5-Fu, and antiangiogenic agents;

Patients had active malignancies other than BTC within 5 years or at the same time.

Clinical symptoms or diseases of the heart that are not well controlled;

Patients with hypertension who cannot be reduced to the normal range by antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Liposomal irinotecan+5-FU/LV+Lenvatinib

    Drug

    Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w Renvastinib: ≥60kg, 12mg; \<60kg, 8mg, PO, once daily 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w

  • NALIRI

    Drug

    Liposomal irinotecan II: calculated as free base, 56.5 mg/m2, IV, d1q2w 5-FU: 1200 mg/ (m2·d) x2d continuous intravenous infusion for 46-48h, q2w LV: 400 mg/m2 intravenously, d1 q2w

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: NALIRI+LenvatinibExperimental treatment 1 intervention
Group B: NALIRIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-free survival

The time between participant randomization and first recorded disease progression or death from any cause, whichever occurs first.

Time frame
5 years

Secondary outcomes

1

Overall survival

Patients were randomized to the time of death from any cause.

Time frame
5 years
2

Objective Response Rate

The proportion of participants in the analyzed population with confirmed complete (CR) or partial response (PR) based on RECIST v1.1

Time frame
5 years
3

Disease control rate

Percentage of cases with confirmed complete response, partial response, and stable disease (≥ 8 weeks) in patients for whom response could be evaluated.

Time frame
5 years
4

Adverse events

Adverse events (AE)/Serious Adverse Events (SAE) (as determined by NCI-CTCAE 5.0).

Time frame
5 years

Other outcomes

Sponsors and contacts

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

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov

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