A Phase 2 interventional study of chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab. in Intrahepatic Cholangiocarcinoma (Icc) and Gall Bladder Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-28.
Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment
For advanced unresectable intrahepatic cholangiocarcinoma and gallbladder cancer, the current standard first-line treatment is a combination of chemotherapy and immunotherapy. However, the efficacy rates remain low. Hepatic artery infusion chemotherapy can reduce systemic drug dosages while increasing local drug concentrations, which is expected to enhance overall efficacy and minimize drug toxicity and side effects.
This study utilized a hepatic artery infusion chemotherapy regimen that combines gemcitabine with oxaliplatin, along with the small molecule tyrosine kinase inhibitor lenvatinib and the immune checkpoint inhibitor toripalimab. The aim was to improve treatment efficacy and create opportunities for conversion surgery. The primary endpoint was the objective response rate, while the secondary endpoints included the surgical resection rate, complete pathological response rate (pCR), overall survival (OS), and the incidence of adverse reactions.
824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.
This study's planned enrollment of 33 is below the median of 50 across 623 interventional studies indexed under Cholangiocarcinoma.
Browse Cholangiocarcinoma studies →Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 494 studies on the registry; 293 are open to participants now.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Triprolizumab: 240mg ivd d1, q3w; Lenvatinib: 8-12mg po qd (body weight\<60kg, 8mg po qd; body weight ≥ 60kg, 12mg po qd); Chemotherapy hepatic arterial infusion (GOLD HAIC): d1 oxaliplatin: 100-125mg+gemcitabine: 800-1000mg; q3w.
Drug: chemotherapy with gemcitabine and oxaliplatin; small molecure TKI lenvatinib; immune-checkpoint inhibitor toripalimab.
Toripalimab: 240mg ivd d1, q3w; Lenvatinib: 8-12mg po qd (body weight\<60kg, 8mg po qd; body weight ≥ 60kg, 12mg po qd) Chemotherapy by hepatic arterial infusion (GOLD HAIC): d1 oxaliplatin: 100-125mg+gemcitabine: 800-1000mg; q3w.
This study also gives Lenvatinib. No intervention listed here names it: that was found by reading the record.
Objective Response Rate (ORR)
Objective Response Rate (ORR) is a key metric commonly used to assess the efficacy of cancer treatments, especially in clinical trials. It primarily measures the proportion of patients who exhibit a significant reduction in tumor size following treatment. Here's a detailed explanation of ORR: 1. Definition: ORR refers to the percentage of patients who experience a notable reduction in tumor size within a specified timeframe after receiving treatment. It typically encompasses two types of responses: Complete Response (CR): The tumor completely disappears, confirmed by follow-up assessments showing no measurable tumor. Partial Response (PR): The tumor size is reduced by a certain percentage (usually 30% or more), but measurable tumor remains. 2. Calculation Method The formula for calculating ORR is as follows: ORR=CR+PR.
Time frame: through study completion, an average of 1 year
Surgical resection rate
Surgical resection rate is the proportion of patients who underwent surgical resection among all patients
Time frame: through study completion, an average of 1 year
Pathological complete response rate (pCR rate)
Pathological complete response rate (pCR rate) is the proportion of patients who underwent surgical resection who achieved pathological complete response.
Time frame: through study completion, an average of 1 year
Overall survival (OS)
Overall survival time (OS) is the time from enrollment in clinical trials to patient death or loss to follow-up.
Time frame: through study completion, an average of 5 years
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Sep 2026, 24 months after the start.
Of 147 non-industry phase 2 interventional studies under Cholangiocarcinoma, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 65. This study's planned 24 months is below that.
Counting every sponsor, half of 173 studies reached it within 46 months; a quarter within 29 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Lenvatinib
Tianjin Medical University Cancer Institute and Hospital →