NCT07760038 Protective Mechanisms of Phycocyanin in Partial Hepatectomy-Associated Liver Injury
| NCT ID | NCT07760038 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Intrahepatic Cholangiocarcinoma (Icc) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-06-01 |
| Primary Completion | 2029-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2026-06-01 with a primary completion date of 2029-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to find out whether phycocyanin, a natural protein from spirulina, can help protect the liver and support recovery in adults having part of their liver removed. The study will also look at whether phycocyanin is safe to take.The main questions are: Does phycocyanin reduce liver injury after surgery? Does it help the liver grow back and recover? What side effects or medical problems happen while taking it? Researchers will compare phycocyanin with a placebo, which looks similar but does not contain phycocyanin. About 30 people will take part. Each person will be randomly placed into one of the two groups, and neither the participants nor the researchers will know which treatment each person receives during the study. Participants will: Take 1.5 grams of phycocyanin or placebo every day for 3 weeks before surgery and 3 weeks after surgery Receive the usual care for liver surgery Give blood and stool samples before and after treatment Allow researchers to study a small piece of liver tissue removed during surgery Return for follow-up for up to 90 days after surgery The samples will be used to check liver function, inflammation, gut bacteria, and changes linked to liver healing. Possible side effects include an allergic reaction or stomach discomfort. The study has been approved by an ethics committee.
Eligibility Criteria
Inclusion Criteria: * Diagnosis of intrahepatic cholangiocarcinoma * Child-Pugh class A liver function * Planned neoadjuvant treatment with gemcitabine plus oxaliplatin, lenvatinib, and a PD-1 inhibitor * Planned anatomical hemihepatectomy with an expected future liver remnant greater than 40% * Age 18 to 75 years * Willing and able to participate and provide written informed consent * No acute illness or significant worsening of symptoms within 4 weeks before enrollment Exclusion Criteria: * Serious coexisting medical conditions * Known allergy to phycocyanin * Other malignant tumors * Previous liver resection * History of severe psychiatric illness that may affect treatment adherence
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07760038 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Intrahepatic Cholangiocarcinoma (Icc). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07760038 currently recruiting?
Yes, NCT07760038 is actively recruiting participants. Contact the research team at cxpeng@zju.edu.cn for enrollment information.
Where is the NCT07760038 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07760038 clinical trial?
NCT07760038 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 30 participants.