Combined Hepatocellular CholangiocarcinomaPhase 1/2NCT06033118
Gemox Combined With Anlotinib and Sintilimab in Advanced cHCC-ICC
A Phase 1/2 study testing gemcitabine ,oxaliplatin,anlotinib,Sintilimab in people with Combined Hepatocellular Cholangiocarcinoma, run by Sichuan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Combined Hepatocellular Cholangiocarcinoma
- What is being tested?
- gemcitabine ,oxaliplatin,anlotinib,Sintilimab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2023to 1 Aug 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- .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;
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- .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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Gemox Combined With Anlotinib and Sintilimab in Advanced Combined Hepatocellular-cholangiocarcinoma: an Exploratory Study
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.
Read the 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 detection rate of cHCC-CCA puncture biopsies and surgical procedures has increased. Oxaliplatin-containing chemotherapy was previously recommended for the treatment of advanced cHCC-ICC, but its efficacy was not satisfactory. Targeted therapy and immunotherapy have made breakthroughs in both advanced HCC and CCA, providing a new direction for exploration in the treatment of advanced cHCC-CCA. Currently, targeted combination immunotherapy has become the preferred first-line treatment strategy for advanced HCC. Chemotherapy combined with immunotherapy is also the preferred first-line treatment option for advanced CCA. To balance the treatment of HCC and ICC, this study further investigates the efficacy and safety of Gemox chemotherapy combined with anlotinib and Sintilimab(anti-PD-1 monoclonal antibody) immunotherapy in advanced cHCC-ICC, to provide a new treatment strategy and reference for the clinical treatment of advanced cHCC-CCA patients.
- Being tested
- gemcitabine ,oxaliplatin,anlotinib,Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine ,oxaliplatin,anlotinib,SintilimabDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Gemox combined with Anlotinib and Sintilimab | Experimental | 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) Receives: Drug: gemcitabine ,oxaliplatin,anlotinib,Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
Measured: Every 2 cycles (each cycle is 21 days)starting from the first cycle, and every 3 cycles after 6 cycles
Secondary outcomes (3)
Safety and tolerability
Incidence of Treatment-Emergent Adverse Events,Version 5.0 and AEs leading to dose interruption or discontinuation.
Measured: 3 months after the last administration of drugs
PFS
Progression-free survival is determined from the date of treatment to PD or death from any cause
Measured: Every 2 cycles(each cycle is 21 days) starting from the first cycle, and every 3 cycles after 6 cycles
OS
OS is the time interval from the start of treatment to death due to any reason or lost of follow-up
Measured: Every 2 cycles(each cycle is 21 days) starting from the first cycle, and every 3 cycles after 6 cycles
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Oct 2023 (estimated)
- Primary completion31 Jul 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Combined Hepatocellular CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Sichuan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhen-Yu Ding, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06033118
- Sponsor's protocol ID
- cHCC-ICC
- Status last verified
- Sep 2023
- First submitted
- 10 Jul 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemox Combined With Anlotinib and Sintilimab in Advanced Combined Hepatocellular-cholangiocarcinoma: an Exploratory Study
- ClinicalTrials.gov ID
- NCT06033118
- Acronym / sponsor ID
- cHCC-ICC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (estimated)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 detection rate of cHCC-CCA puncture biopsies and surgical procedures has increased. Oxaliplatin-containing chemotherapy was previously recommended for the treatment of advanced cHCC-ICC, but its efficacy was not satisfactory. Targeted therapy and immunotherapy have made breakthroughs in both advanced HCC and CCA, providing a new direction for exploration in the treatment of advanced cHCC-CCA. Currently, targeted combination immunotherapy has become the preferred first-line treatment strategy for advanced HCC. Chemotherapy combined with immunotherapy is also the preferred first-line treatment option for advanced CCA. To balance the treatment of HCC and ICC, this study further investigates the efficacy and safety of Gemox chemotherapy combined with anlotinib and Sintilimab(anti-PD-1 monoclonal antibody) immunotherapy in advanced cHCC-ICC, to provide a new treatment strategy and reference for the clinical treatment of advanced cHCC-CCA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemox combined with Anlotinib and Sintilimab | Experimental | Drug: gemcitabine ,oxaliplatin,anlotinib,SintilimabGemox 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) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- .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;
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabine ,oxaliplatin,anlotinib,SintilimabGemox 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) | Drug | Gemox combined with Anlotinib and Sintilimab |
Primary outcome
ORR
Time frame: Every 2 cycles (each cycle is 21 days)starting from the first cycle, and every 3 cycles after 6 cycles
Objective Response Rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version. 1.1
3 secondary outcomes
Safety and tolerability
Time frame: 3 months after the last administration of drugs
PFS
Time frame: Every 2 cycles(each cycle is 21 days) starting from the first cycle, and every 3 cycles after 6 cycles
OS
Time frame: Every 2 cycles(each cycle is 21 days) starting from the first cycle, and every 3 cycles after 6 cycles
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing gemcitabine ,oxaliplatin,anlotinib,Sintilimab in people with Combined Hepatocellular Cholangiocarcinoma, run by Sichuan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu Yang, M.D (18980606616, yangyuflying@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: Every 2 cycles (each cycle is 21 days)starting from the first cycle, and every 3 cycles after 6 cycles). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.