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Compares treatment options for Biliary Tract Neoplasms Immunotherapy
Official title A Phase II Study of Adjuvant Durvalumab Combined With GEMOX/GC Chemotherapy Followed by Lenvatinib Versus Capecitabine in Biliary Tract Cancer.
ClinicalTrials.gov ID: NCT07679399
What this study is testing
What is Durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib?
Durvalumab plus GEMOX/GC chemotherapy sequentially followed by lenvatinib is an investigational medicine, being studied as a potential treatment for biliary tract neoplasms immunotherapy.
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 study is designed as a prospective, randomized, open-label, phase II clinical trial to systematically evaluate the efficacy and safety of durvalumab combined with GEMOX/GC chemotherapy followed by lenvatinib, compared with capecitabine monotherapy, as adjuvant therapy for biliary tract cancer (BTC) after curative-intent resection.The primary objective is to determine whether the combination regimen can significantly improve the 1-year recurrence-free survival (RFS) rate. Secondary objectives include assessment of overall survival (OS) and the incidence of treatment-related adverse events.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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
- The people voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated with the...
- When signing the informed consent form, one must be at least 18 years old and no older than 75 years old, and there is no restriction on gender.
- Histologically confirmed cholangiocarcinoma or gallbladder cancer (excluding pancreatic cancer or ampullary cancer)
- Having undergone radical surgical treatment (R0 or R1 resection)
- The ECOG score is between 0 and 1
You likely can't join if
- Pancreatic cancer or ampullary cancer
- Not yet fully recovered from the surgery or with unremoved bile duct obstruction
- Pregnant women (with a positive pregnancy test before taking the medicine) or lactating women
- Having had other untreated malignant tumors in the past (within the last 5 years) or simultaneously, excluding cured skin basal cell carcinoma, skin...
- Who has previously received immunotherapy or chemotherapy
- Serious coexisting diseases that may interfere with the treatment of the proposed plan, including potential severe infections
See the full eligibility criteria
- The people voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated with the follow-up.
- When signing the informed consent form, one must be at least 18 years old and no older than 75 years old, and there is no restriction on gender.
- Histologically confirmed cholangiocarcinoma or gallbladder cancer (excluding pancreatic cancer or ampullary cancer)
- Having undergone radical surgical treatment (R0 or R1 resection)
- The ECOG score is between 0 and 1
- The hematology and organ functions are adequate. Based on the following laboratory test results obtained within 14 days prior to the start of the treatment (unless otherwise specified)
- Blood routine test: (Within 14 days before screening, no blood transfusion, no use of G-CSF, and no use of drugs for correction) Hb ≥ 90 g/L; Neutrophils ≥ 1.5 × 10\^9/L; PLT ≥100×10\^9/L
- Biochemical test: (No albumin transfusion within 14 days)
- Appropriate liver function: ALT and AST ≤ 2.5 × ULN; serum bilirubin ≤ 2.0 × normal upper limit (ULN); these conditions do not apply to patients with confirmed Gilbert syndrome. Any clinically significant biliary...
- Coagulation function: International Normalized Ratio (INR) ≤ 1.5
- Fertile women: Agree to abstain from sexual intercourse (avoiding heterosexual intercourse) or use a contraceptive method with a failure rate of less than 1% during the treatment period and for at least 6 months after...
- Male: Agree to abstinence (not engaging in heterosexual sexual intercourse) or use of contraceptive measures, agree not to donate sperm, defined as follows: When the female partner has reproductive capacity, the male...
- Pancreatic cancer or ampullary cancer
- Not yet fully recovered from the surgery or with unremoved bile duct obstruction
- Pregnant women (with a positive pregnancy test before taking the medicine) or lactating women
- Having had other untreated malignant tumors in the past (within the last 5 years) or simultaneously, excluding cured skin basal cell carcinoma, skin squamous cell carcinoma, in situ breast cancer and in situ cervical...
- Who has previously received immunotherapy or chemotherapy
- Serious coexisting diseases that may interfere with the treatment of the proposed plan, including potential severe infections
- There is drug abuse; or any medical, psychological or social condition that may affect the research, the patient's compliance, be unstable, or even potentially endanger the patient's safety.
- Significant clinical cardiovascular and cerebrovascular diseases, including but not limited to acute myocardial infarction occurring within 6 months prior to enrollment, severe/unstable angina pectoris, cerebrovascular...
- Presence of persistent infection of grade 2 or above (CTCAE 5.0)
- Having a history of thromboembolic events within the past 6 months (including stroke and/or transient ischemic attack)
- Hypertension that has not been well controlled by antihypertensive drugs (systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg)
- Participants who had active autoimmune diseases or autoimmune disease history in the past two years; those with active, known, or suspected autoimmune diseases that may affect important organ functions or that may...
- A known history of active tuberculosis (with the tuberculosis bacteria)
- Those who have a history of gastrointestinal bleeding within the past 6 months or have a clear tendency towards gastrointestinal bleeding, such as esophageal varices with bleeding risk, active gastrointestinal ulcer...
- Severe non-healing wounds, ulcers or fractures
- There are unresolved toxicities of grade \> 1 that were caused by any previous treatment/operation (CTCAE 5.0, except for hair loss, anemia, and hypothyroidism)
- Patients who have objective evidence of severe lung function impairment in the past and at present, such as a history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, or...
- After the researchers' comprehensive assessment of the patient's condition, it was determined that the patient was not suitable for participating in this study.
- At the same time, he/she was also involved in another clinical study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, 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 Beijing, 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.