ClinicalTrials.gg
RecruitingNCT07760038Updated Aug 12, 2026

Protective Mechanisms of Phycocyanin in Partial Hepatectomy-Associated Liver Injury

An interventional study of Phycocyanin and Maltodextrin in Intrahepatic Cholangiocarcinoma (Icc) and Liver Injury, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 229 studies in Cholangiocarcinoma with a site in China — 113 open to participants now, 124 under way, 12 of them phase 3. Cholangiocarcinoma · China.

Planned enrollment
139th of 190
30 · median 51
Started
2026
with 20 others
No phase
33 of 229
14 open now
Primary completion
2029-05
later than 112 of 123 live
Registered
221st of 229
by date

Among the 229 studies in Cholangiocarcinoma with a site in China, this one is the 139th largest by planned enrollment of the 190 interventional ones that give a count, is one of 21 that started in 2026, is one of 33 with no phase, reaches primary completion later than 112 of the 123 other live ones, and was the 221st registered.

Cholangiocarcinoma

824 studies on the registry are indexed under Cholangiocarcinoma; 287 are open to participants now.

Browse Cholangiocarcinoma studies →

Open to participants now

113 of the 229 studies in Cholangiocarcinoma with a site in China are open now. Recruiting first, the newest first:

107 more — sign in →

All 113 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 211 Cholangiocarcinoma studies recruiting now, 141 (67%) set no upper age limit and 49 (23%) stop at 75 or younger; 10 take children under 18; 14 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

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02

Study 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.

03

Conditions studied

  • Intrahepatic Cholangiocarcinoma (Icc)
  • Liver Injury
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diagnosis of intrahepatic cholangiocarcinoma
  • class A liver function
  • Planned treatment with gemcitabine plus oxaliplatin, lenvatinib, and a 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
  • No acute illness or significant worsening of symptoms within 4 weeks before enrollment

Exclusion criteria

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
Terms in these criteria, in plain language(4)

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.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumor sample. Some scores count stained tumor cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

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 authorized 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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Phycocyanin Group

    Participants will take 1.5 grams of phycocyanin by mouth once a day for 3 weeks before surgery and 3 weeks after surgery. They will also receive the usual medical care for partial liver removal surgery.

    Dietary Supplement: Phycocyanin

  • Placebo comparator
    Placebo Group

    Participants will take 1.5 grams of maltodextrin placebo by mouth once a day for 3 weeks before surgery and 3 weeks after surgery. The placebo does not contain phycocyanin. Participants will also receive the usual medical care for partial liver removal surgery.

    Dietary Supplement: Maltodextrin

Interventions

  • Dietary supplementPhycocyanin

    Participants will take 1.5 grams of phycocyanin by mouth once daily for 3 weeks before partial hepatectomy and for 3 weeks after surgery. Phycocyanin is a natural protein from spirulina.

  • Dietary supplementMaltodextrin

    Participants will take 1.5 grams of maltodextrin placebo by mouth once daily for 3 weeks before partial hepatectomy and for 3 weeks after surgery. The placebo does not contain phycocyanin.

06

What researchers measure

Primary outcomes

  1. Change in Serum Aspartate Aminotransferase (AST) Level

    Time frame: Baseline and Week 3 after surgery

  2. Change in Serum Alanine Aminotransferase (ALT) Level

    Time frame: Baseline and Week 3 after surgery

  3. Change in Serum Total Bilirubin (TBIL) Level

    Time frame: Baseline and Week 3 after surgery

Secondary outcomes

  1. Change in Blood Inflammatory Marker Levels

    Time frame: Baseline and Week 3 after surgery

  2. Liver Cell Proliferation Assessed by Ki-67 Expression

    Time frame: Baseline and Week 3 after surgery

  3. Liver Cell Proliferation Assessed by PCNA Expression

    Time frame: Baseline and Week 3 after surgery

Other outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for May 2029, 35 months after the start.

Of 66 non-industry interventional studies with no phase under Cholangiocarcinoma, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 28. This study's planned 35 months is below that.

Counting every sponsor, half of 67 studies reached it within 43 months; a quarter within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2026
First posted
Aug 12, 2026
StartActual
Jun 1, 2026
Primary completionEst.
May 30, 2029
CompletionEst.
May 30, 2029
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07760038
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Jun 1, 2026
Primary completion
May 30, 2029 (estimated)
Completion
May 30, 2029 (estimated)
Last update
Aug 12, 2026

Study contacts

Xiaopeng Cai
Contact
cxpeng@zju.edu.cn
+86 18768161626

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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