Status:
NOT_YET_RECRUITING
Gemox Combined With Anlotinib and Sintilimab in Advanced cHCC-ICC
Lead Sponsor:
Sichuan University
Conditions:
Combined Hepatocellular Cholangiocarcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief 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-cholangiocarcin...
Detailed Description
Combined hepatocellular-cholangiocarcinoma (cHCC-CCA) accounts for 0.4%-14.2% of primary hepatocellular carcinoma. As imaging and pathological diagnostic techniques for liver tumors have improved, the...
Eligibility Criteria
Inclusion
- .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.
- .Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
Exclusion
- 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;
- Untreated active hepatitis B. (Note: Hepatitis B patients who receive antiviral treatment and whose HBV Viral load is less than 2000IU/ml can be allowed to participate in the study)
- Active hepatitis C, that is, those who are anti-HCV positive or HCV-RNA positive and have abnormal liver function;
- Having a history of psychotropic substance abuse, unable to quit, or having a history of mental disorders;
- Patients who received solid organ transplantation or bone marrow transplantation, or had active autoimmune diseases requiring systemic Sex therapy within 2 years before the first administration;
- Existence of immune deficiency diseases or HIV infection;
- There has been objective evidence that Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia and serious impairment of lung function exist in the past or at present;
- Major surgery on the liver or other parts has been performed within 4 weeks before the first administration, or minor surgery (such as simple resection, tooth extraction, etc.) has been performed within 1 week before the first administration;
- Received the vaccine within 30 days before the first administration;
- Abdominal fistula, gastrointestinal perforation, or abdominal abscess occurred within 4 weeks prior to the first administration;
- For any significant clinical and laboratory abnormalities, the researchers believe that they will affect the safety evaluators, such as: active infection requiring systemic Sex therapy, uncontrollable diabetes, hypertension patients who cannot fall to the normal range (systolic pressure\>140mmHg, diastolic pressure\>90mmHg), myocardial infarction within 6 months, thyroid dysfunction (\>NCI CTCAE v4.0 Level 1 standard) after treatment with two or less antihypertensive drugs;
- Researchers believe that it is not suitable for inclusion in the study.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06033118
Start Date
October 1 2023
End Date
August 1 2026
Last Update
September 13 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.