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New treatment option for Intrahepatic Cholangiocarcinoma
Official title Toripalimab Plus Lenvatinib and Gemcitabine-based Chemotherapy in 1L Treatment of Advanced ICC: a Phase III Study
ClinicalTrials.gov ID: NCT05342194
What this study is testing
What is Toripalimab?
Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intrahepatic cholangiocarcinoma.
Also referred to as Tuoyi.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase III, prospective, randomized, three-arm, double-blind, placebo-controlled, international multicenter study to evaluate the efficacy and safety of toripalimab in combination with lenvatinib and gemcitabine-based chemotherapy compared with gemcitabine-based chemotherapy as first-line treatment for unresectable advanced ICC. This study will enroll approximately 480 patients with unresectable advanced ICC who have received no prior systemic therapy.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age of 18-75 years (inclusive), male or female;
- Volunteer to participate in the study by signing the informed consent form and the ability to comply with the study protocol;
- Advanced ICC with diagnosis confirmed by histology or cytology;
- Stage II, III, or IV per TNM staging for ICC of the American Joint Committee on Cancer (AJCC) (8th edition, 2017). Those with Stage II or III should...
- Patients with no prior systemic chemotherapy or targeted therapy or loco-regional therapy (including but not limited to transarterial...
You likely can't join if
- Diagnosis of hepatocellular carcinoma (HCC), mixed cholangiocarcinoma and HCC, sarcomatoid hepatocellular carcinoma, or hepatic fibrolamellar...
- History of malignancy other than ICC within 5 years prior to screening, with the exception of localized malignancies that have been cured, including...
- Prior radiotherapy for ICC within 4 weeks prior to randomization;
- Major surgical procedures within 4 weeks prior to randomization;
- Side effects from prior therapy (except alopecia and pigmentation) that has not recovered to ≤ grade 1 (per NCI-CTCAE v5.0) or levels specified in...
- Uncontrolled pericardial effusion, pleural effusion, or clinically significant moderate or severe ascites that is symptomatic or requires...
See the full eligibility criteria
- Age of 18-75 years (inclusive), male or female;
- Volunteer to participate in the study by signing the informed consent form and the ability to comply with the study protocol;
- Advanced ICC with diagnosis confirmed by histology or cytology;
- Stage II, III, or IV per TNM staging for ICC of the American Joint Committee on Cancer (AJCC) (8th edition, 2017). Those with Stage II or III should be determined to be unresectable by the investigator;
- Patients with no prior systemic chemotherapy or targeted therapy or loco-regional therapy (including but not limited to transarterial chemoembolization, transarterial embolization, transarterial chemotherapy or...
- Measurable lesion per RECIST v1.1;
- Child-Pugh class A with no history of hepatic encephalopathy;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1;
- Life expectancy ≥12 weeks;
- Diagnosis of hepatocellular carcinoma (HCC), mixed cholangiocarcinoma and HCC, sarcomatoid hepatocellular carcinoma, or hepatic fibrolamellar carcinoma by histology or cytology;
- History of malignancy other than ICC within 5 years prior to screening, with the exception of localized malignancies that have been cured, including non-melanoma skin cancers, cervical carcinoma in situ, breast...
- Prior radiotherapy for ICC within 4 weeks prior to randomization;
- Major surgical procedures within 4 weeks prior to randomization;
- Side effects from prior therapy (except alopecia and pigmentation) that has not recovered to ≤ grade 1 (per NCI-CTCAE v5.0) or levels specified in the inclusion/exclusion criteria;
- Uncontrolled pericardial effusion, pleural effusion, or clinically significant moderate or severe ascites that is symptomatic or requires thoracentesis or paracentesis during the screening phase for control of symptoms;
- Gastrointestinal (GI) hemorrhage within 6 months prior to randomization and/or gastrointestinal varices that have not been assessed and treated, if appropriate, within 6 months prior to randomization.
- Gastrointestinal or non-gastrointestinal fistula, gastrointestinal perforation, or abdominal abscess within 6 months prior to randomization;
- Ongoing or a history of recurrent intestinal obstruction. Patients with a single episode of intestinal obstruction that has fully resolved following treatment are eligible allowed;
- History of serious cardiovascular and cerebrovascular diseases:
- Significant bleeding and coagulopathy or other evidence of bleeding diathesis, to include:
- Pre-existing CNS metastases and/or meningeal metastases (including dural metastases and leptomeningeal metastases);
- Serious non-healing wound, active ulcer, or untreated bone fracture;
- Vaccination with live virus or bacteria within 30 days prior to randomization;
- Active autoimmune disease or history of autoimmune disease
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.