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Colorectal CarcinomaPhase 1/2NCT07025850

Efficacy Study of Digoxin Combined With Serplulimab and Chemotherapy in First-Line Treatment of MSS Advanced Colorectal Cancer

A Phase 1/2 study testing Digoxin, Fuquinitinib and Tislelizumab in people with Colorectal Carcinoma, run by Fudan University at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Efficacy Study of Digoxin Combined with Serplulimab and Chemotherapy in First-Line Treatment of MSS Advanced Colorectal Cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Carcinoma
What is being tested?
Digoxin, Fuquinitinib and Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesChina
Study dates
1 Aug 2025to 1 May 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥18 years old, both sexes;
  • Patients with histologically or cytologically confirmed unresectable and metastatic CRC;
  • Recist1.1-defined disease progression or intolerance to prior standard therapy during or after standard therapy. Standard therapy was required to include all the following agents: fluorouracilines, chemotherapy agents such as irinotecan, and oxaliplatin, with or without an anti-VEGF monoclonal antibody (e.g., bevacizumab). Left-sided KRAS/NRAS/BRAF wild-type subjects received combined anti-EGFR mAb (cetuximab or panitumumab).
  • Before enrollment, the tumor tissue was pMMR by immunohistochemistry, or MSS or MSI-L by PCR or NGS;
  • Patients with ECOG score of 0-1 and expected survival time ≥3 months, patients who can cooperate to observe adverse reactions and efficacy;
  • At least one measurable tumor lesion according to RECIST 1.1 criteria;
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  • Good organ function:
  • neutrophil ≥1.5*109/L; Platelet ≥100*109/L; Hemoglobin ≥9g/dl; Serum albumin ≥3g/dl;
  • Thyroid stimulating hormone (TSH) ≤ 1 times the upper limit of normal, T3 and T4 in the normal range;
  • bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST≤ 2 times the upper limit of normal;
  • Serum creatinine ≤ 1.5 times the upper limit of normal, creatinine clearance ≥60ml/min;
  • International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the upper limit of the normal range, unless the patient is receiving anticoagulant therapy and the PT value is within the intended range for anticoagulant therapy;
  • Activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal;
  • There were no serious concomitant diseases that could make the survival time less than 5 years;
  • Negative pregnancy test in female subjects (for female patients of childbearing potential); Infertile female patients;
  • Male patients of childbearing potential and female patients of childbearing potential and at risk of pregnancy must agree to use adequate contraception for the entire duration of the study and for 12 months after receiving treatment with the protocol;
  • Signed and dated informed consent indicating that the patient has been informed about all relevant aspects of the study;
  • Patients who are willing and able to comply with the visit schedule, treatment plan, laboratory tests, and other study procedures;
  • Willing to comply with the arrangement during the study period can not participate in any other clinical research on drugs and medical devices.

Who cannot join

  • Pathological diagnosis of other intestinal tumors, such as gastrointestinal stromal tumor;
  • Tumor tissues were dMMR detected by immunohistochemistry, or MSI-H detected by PCR or NGS
  • Prior treatment with PD-1 antibody, PD-L1 antibody, or CTLA-4 antibody;
  • Previous or concurrent history of other malignant tumors, excluding adequately treated non-melanoma skin cancer, cervical carcinoma in situ and thyroid papillary carcinoma;
  • Active autoimmune disease, history of autoimmune disease (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes); It does not include autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone; Type I diabetes on stable doses of insulin; Vitiligo or cured childhood asthma/allergy without any intervention in adulthood;
  • A history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation or allogeneic bone marrow transplantation;
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  • Contraindications to antiangiogenic drugs (such as active bleeding, gastrointestinal bleeding, hemoptysis, etc.);
  • History of interstitial lung disease (excluding radiation pneumonitis without steroid treatment) and non-infectious pneumonia;
  • Patients with active pulmonary tuberculosis infection detected by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active pulmonary tuberculosis infection more than 1 year before enrollment but without regular treatment;
  • The subject has active hepatitis B (HBV DNA ≥2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the detection limit of the assay)
  • Severe cardiopulmonary and renal dysfunction;
  • Have hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);
  • A history of psychotropic substance abuse, alcohol or drug abuse;
  • Other factors that may affect subject safety or trial compliance as judged by the investigator. Severe medical conditions requiring concomitant treatment (including mental illness), serious laboratory abnormalities, or other family or social factors.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Dawei Li, PhD contact

+8613774201693

li_dawei@fudan.edu.cn

China2 sites

  • Anyang Cancer Hospital

    Anyang, Henan

    Yanjun Wang, +86-0372-2232178

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200030

    Dawei Li, 13774201693, li_dawei@fudan.edu.cn

Other trials in China

About this study

Official title: Phase II Clinical Study of Digoxin Combined With Fruquintinib and Tislelizumab in Patients With Advanced Primary Colorectal Cancer Who Failed Standard Therapy

Efficacy Study of Digoxin Combined with Serplulimab and Chemotherapy in First-Line Treatment of MSS Advanced Colorectal Cancer

Being tested
Digoxin, Fuquinitinib, Tislelizumab
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DigoxinDrug

    p.o. 0.5mg q.d.

  • FuquinitinibDrug

    Fuquinitinib: 5mg (QD) orally for 2 weeks, 1 week off, repeated every 3 weeks until disease progression or intolerable toxicity.

  • TislelizumabDrug

    Tislelizumab: 200mg intravenously every 3 weeks (Q3W), was administered until the occurrence of unacceptable toxic effects, or disease progression, withdrawal of consent, or withdrawal as judged by the investigator.

Study groups in NCT07025850
Study groupRoleWhat they receive
Digoxin in combination with Serplulimab and ChemotherapyExperimentalDigoxin in combination with Serplulimab and Chemotherapy
Receives: Drug: Digoxin; Drug: Fuquinitinib; Drug: Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. objective response rate (ORR)

    Measured: 2 years

Secondary outcomes (3)

  1. progression-free survival (PFS)

    Measured: 2 years

  2. overall survival (OS)

    Measured: 2 years

  3. disease control rate (DCRs)

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2025
  2. Study start1 Aug 2025 (estimated)
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07025850
Sponsor's protocol ID
Dynamic
Status last verified
Jun 2025
First submitted
10 Jun 2025
Last updated
1 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Digoxin, Fuquinitinib and Tislelizumab in people with Colorectal Carcinoma, run by Fudan University at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dawei Li, PhD (+8613774201693, li_dawei@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (ORR) (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07025850.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.

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