Not Yet RecruitingPhase 1/2

Gemox Combined With Anlotinib and Sintilimab in Advanced cHCC-ICC

25 participantsStarted 2023-10-01

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. .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;
✓. .ECOG PS 0-1;
✓. .Child Pugh A/B ≤ 7;
✓. .Adequate organ function including the following:Total bilirubin ≤1.5 times upper limit of normal (ULN),Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3×ULN,Alkaline phosphatase≤2.5×ULN (If the tumor invaded the liver, ≤3×ULN), Serum creatinine≤1.5×ULN,Serum amylase and lipase≤1.5×ULN,International standardized ratio (INR)/partial prothrombin time (PTT)≤1.5×ULN;Platelet count ≥ 75,000 /mm3.Hemoglobin (Hb) ≥ 9 g/dL.Absolute neutrophil count (ANC) ≥ 1500/mm3.
✓. .Strict contraception.

Exclusion criteria

✕. 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;
✕. Active bleeding or abnormal coagulation function (PT\>16s, APTT\>43s, INR\>1.5) × ULN), with a tendency to bleed or undergoing thrombolysis, anticoagulation, or antiplatelet therapy;
✕. Hepatic encephalopathy;
✕. Within the past 6 months, there has been a history of gastrointestinal bleeding or a clear tendency for gastrointestinal bleeding, such as known local active ulcer lesions, fecal occult blood+or above, which cannot be included in the group; If there is continuous fecal occult blood, gastroscopy should be performed;
✕. Patients with severe gastroesophageal varices who require interventional treatment;

What they're measuring

ORR

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

Trial details

NCT IDNCT06033118

SponsorSichuan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-31

Contact for this trial

Yu Yang, M.D

18980606616 yangyuflying@hotmail.com

View on ClinicalTrials.gov More Combined Hepatocellular Cholangiocarcinoma trials