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Gemox Combined With Anlotinib and Sintilimab in Advanced cHCC-ICC

ConditionCombined Hepatocellular Cholangiocarcinoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University

About this trial

The Purpose of This Study is to Evaluate the Efficacy and Safety of Gemox combined with Anlotinib and Sintilimab as first-lineTherapy for Patients With advanced combined hepatocellular-cholangiocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

.Age 18-75 years;

.Histologically or cytologically confirmed diagnosis of aCombined hepatocellular-cholangiocarcinoma;

.Non resectable or metastatic cHCC-ICC patients who have not received systemic treatment or first-line treatment progress (only non arotinib Targeted therapy or non GEMOX chemotherapy) in the past, and have at least one measurable lesion (RECIST v1.1);

.Life expectancy ≥ 3 months;

Disqualifiers

Has a history of severe allergic reactions to chimeric, human or humanized antibodies, or fusion proteins.

Pregnant or lactating women, men and women of childbearing age who are unwilling or unable to take effective contraceptive measures;

History of other malignant tumors in the past 5 years, except for malignant tumors that have received treatment for the purpose of cure, and have no known active diseases for ≥ 5 years before the first administration, and have a low potential risk of recurrence; Fully treated non Melanoma skin cancer or malignant lentigo without disease evidence; Fully treated Carcinoma in situ, no disease evidence;

Moderate or higher amounts of pleural and ascitic fluid with clinical symptoms;

Trial design

Design model

Single group

Treatments tested in this trial

  • gemcitabine ,oxaliplatin,anlotinib,Sintilimab

    Drug

    Gemox chemotherapy（gemcitabine 1g/m2 ivgtt d1,d8 +oxaliplatin 85g/m2 ivgtt d1，q3w，anlotinib (8mg po d1-14 q3w )and Sintilimab (200mg ivgtt d1 q3w)

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Gemox combined with Anlotinib and SintilimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

ORR

Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1

Time frame
Every 2 cycles (each cycle is 21 days)starting from the first cycle, and every 3 cycles after 6 cycles

Secondary outcomes

1

Safety and tolerability

Incidence of Treatment-Emergent Adverse Events,Version 5.0 and AEs leading to dose interruption or discontinuation.

Time frame
3 months after the last administration of drugs
2

PFS

Progression-free survival is determined from the date of treatment to PD or death from any cause

Time frame
Every 2 cycles(each cycle is 21 days) starting from the first cycle, and every 3 cycles after 6 cycles
3

OS

OS is the time interval from the start of treatment to death due to any reason or lost of follow-up

Time frame
Every 2 cycles(each cycle is 21 days) starting from the first cycle, and every 3 cycles after 6 cycles

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Sichuan University

Lead sponsor

Source ClinicalTrials.gov

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