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Could a simple fruit acid boost cancer treatment?

NCT ID NCT07325123

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests whether adding malic acid (a natural fruit acid) to standard immunotherapy is safe for people with solid tumors like colorectal, lung, or melanoma cancer. About 30 participants will take malic acid by mouth while continuing their immunotherapy. The main goal is to check safety and find the right dose, while also looking at basic health markers like blood counts, weight, and appetite.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged ≥ 18 years (inclusive), male or female; * Patients with malignant solid tumors such as colorectal cancer, lung cancer, and melanoma, confirmed by histopathological or cytological examination; * Patients have at least one measurable lesion; * Undergoing systematic anti-tumor treatment with immunotherapy; * Expected survival time ≥ 3 months; * Basic functions of major organs are norma,laboratory tests meet the following criteria:Hematology (No blood transfusion or blood products administered, and no use of G-CSF or other hematopoietic stimulants for correction within 7 days prior to laboratory testing): Absolute neutrophil count ≥ 1.5×10⁹/L; Platelets ≥ 75×10⁹/L; Hemoglobin ≥ 90g/L. Kidney: Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) \> 60ml/min/1.73m² (Cockcroft-Gault formula). Liver: Serum total bilirubin \< 1.5×ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 2.5×ULN or ≤ 5×ULN (for subjects with liver metastases); Albumin (ALB) ≥ 30g/L. Coagulation function: International normalized ratio (INR) or prothrombin time (PT) \< 1.5×ULN. For subjects receiving anticoagulant therapy, it is acceptable as long as PT is within the intended range for the anticoagulant used.l; * For female subjects of childbearing age during the screening period, the serum pregnancy test result must be negative; female/male subjects of reproductive potential must be willing to use reliable contraceptive methods throughout the entire study period (i.e., from signing the informed consent form to 90 days after the last administration of the study drug), including but not limited to: abstinence, vasectomy of the male partner, female sterilization, effective intrauterine devices (IUDs), and effective contraceptive medications. * Patients voluntarily participate in this study, sign the informed consent form, and have good compliance. Exclusion Criteria: * Subjects who have not recovered from adverse events caused by any intervention to ≤ Grade 1 (except for alopecia, hearing impairment, and Grade ≤ 2 neurological or endocrine disorders requiring replacement therapy) prior to the first dose; * Subjects who have undergone major or moderate surgery (other than for diagnosis or biopsy) within 28 days prior to the first dose, or are expected to undergo major surgery during the study; * Subjects with severe chronic obstructive pulmonary disease (COPD) (Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] ≥ Grade 3), or who have had intestinal adhesions or intestinal obstruction within 6 months prior to the first dose; * Subjects with severe cardiovascular diseases, such as New York Heart Association (NYHA) Heart Disease (Class III or higher), myocardial infarction within 6 months, current unstable angina, or uncontrolled hypertension (systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 100 mmHg); * Subjects with uncontrolled primary brain tumors or central nervous system (CNS) metastases, with significant intracranial hypertension or neuropsychiatric symptoms; * Subjects with uncontrollable neuropsychiatric diseases, mental disorders, or substance abuse, which may affect trial compliance; * Subjects with active infections requiring systemic treatment; * Subjects with a known history of human immunodeficiency virus (HIV) infection; * Subjects with hepatitis B virus (HBV) infection (HBsAg-positive or HBcAb-positive, with HBV-DNA ≥ 2000 IU/mL or HBV-DNA ≥ 10⁴ copies/mL), or hepatitis C virus (HCV) infection (HCV antibody-positive, with HCV-RNA quantitative test result above the lower limit of detection); Note: For subjects with HBV infection and HBV-DNA \< 2000 IU/mL or HBV-DNA \< 10⁴ copies/mL, those who are willing to receive antiviral therapy (such as entecavir, tenofovir, or other antiviral drugs) based on clinical judgment during the study may be enrolled; * Subjects with medical history, diseases, treatments, or laboratory abnormalities that may interfere with trial results, prevent the subject from completing the entire study, or are deemed by the investigator as not being in the subject's best interest to participate in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  2. A doctor treating you

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More trials for these conditions

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