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Colo-rectal CancerPhase 2NCT06218888

A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Microsatellite Stabilized (MSS/pMMR) Colorectal Cancer With Liver Metastases

A Phase 2 study testing Tislelizumab, Fruquintinib and Chidamide in people with Colo-rectal Cancer, run by Fujian Cancer Hospital.

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
Search all trials

Trial summary

To explore the Efficacy and Safety of Tislelizumab combined with fruquintinib and Chidamide in the treatment of unresectable or advanced microsatellite stabilized (MSS/pMMR) colorectal cancer with liver metastases Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colo-rectal Cancer
What is being tested?
Tislelizumab, Fruquintinib and Chidamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
No sites listed yet
Study dates
1 Jun 2024to 1 Dec 2026
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged ≥ 18 years old and ≤ 75 years old.
  • Expected survival time ≥ 18 weeks.
  • Diagnosis of pMMR confirmed by PCR for microsatellite stability (MSS) or low microsatellite instability (MSI-L), or by immunohistochemistry for DNA mismatch repair (MMR) proteins, including MLH1, MSH2, MSH6 and PMS2 protein expression, which result in no protein deletion.
  • Subjects with histologically and/or cytologically confirmed locally advanced unresectable or metastatic colorectal adenocarcinoma with liver metastasis (excluding adenosquamous carcinoma mixed with other pathological types).
  • ECOG PS score is in the range of 0~1.
  • Failure of previous treatment with fluorouracil, oxaliplatin, and irinotecan based chemotherapy, with imaging evidence (such as CT scans) or clinical evidence (such as cytological reports of new ascites or pleural effusion) demonstrating disease progression during or after treatment, or discontinuation of treatment due to toxicity intolerance.
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  • Subjects having adequate organ and bone marrow functions with laboratory test values within 7 days prior to enrollment meeting the following requirements, as follows:
  • Blood routine: absolute neutrophil count (ANC) ≥ 1.5×109/L; platelet count (PLT) ≥ 100×109/L; hemoglobin level (HGB) ≥ 9.0 g/dL.
  • Liver function: serum total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN in subjects without liver metastases, and ALT and AST ≤ 5.0 × ULN in subjects with liver metastases; serum albumin ≥ 25 g/L.
  • Renal function: serum creatinine (Cr) ≤ 1.5 x ULN. 4) Patients with routine urine results showing urine protein <2+ or routine urine testing showing urine protein ≥ 2+ at baseline should undergo 24-hour urine collection and 24-hour urine protein quantification < 1 g.
  • 5) Coagulation function: international normalized ratio (INR) ≤ 1.5×ULN and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.

Who cannot join

  • Prior exposure to any anti-PD-1 antibody, anti-PD-L1 antibody, HDAC inhibitor, or irinotecan.
  • Receiving any investigational drug within 4 weeks prior to the first dose of the study drug.
  • Concurrent participation in another interventional clinical study, except in an observational (non-interventional) clinical study or in the follow-up phase of an interventional study.
  • Receiving the last dose of antitumor therapy (chemotherapy, targeted therapy, tumor immunotherapy, or tumor embolization) within 3 weeks prior to the first dose.
  • Receiving radiotherapy within 4 weeks prior to the first dose.
  • Patients who have received radiotherapy more than 4 weeks prior to the first dose with any radiotherapy-related toxic reactions, such as radiation pneumonia, radiation hepatitis, radiation enteritis, including clinical symptoms only, or requiring glucocorticoid therapy.
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  • Use of immunosuppressive drugs within 4 weeks prior to the first dose, excluding topical glucocorticoids by nasal spray, inhalation or other routes or physiological doses of systemic glucocorticoids (i.e., no more than 10 mg/day prednisone or equivalent doses of other glucocorticoids).
  • Receiving live attenuated vaccine within 4 weeks prior to the first dose or planning to receive during the study period.
  • Major surgical procedure (craniotomy, thoracotomy or open heart surgery) or unhealed wound, ulcer or fracture within 4 weeks prior to the first dose.
  • Presence of toxicity (excluding alopecia, non-clinically significant and asymptomatic laboratory abnormalities) from prior antineoplastic therapy not recovered to ≤ grade 1 by NCI common terminology criteriafor adverse events (CTCAE) Version 5.0 (NCI CTCAE Version 5.0) prior to the first dose.
  • Known presence of symptomatic CNS metastases and/or carcinomatous meningitis. Subjects with prior treatment for brain metastases may participate in the study provided that the brain metastases have remained stable for at least 4 weeks prior to the first dose of study treatment; and that neurological symptoms have recovered to ≤ grade 1 by NCI CTCAE version 5.0.
  • Active autoimmune disease requiring systemic therapy (e.g., use of disease-relieving drugs, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Alternative therapies (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) are allowed. A known history of primary immunodeficiency. For patients with only positive autoimmune antibodies, the presence of autoimmune diseases should be confirmed at the discretion of the investigator.
  • Patients who are known to have active tuberculosis and are receiving anti-tuberculosis treatment or have received anti-tuberculosis treatment within 1 year prior to the first dose.
  • Known to have interstitial lung disease requiring steroid hormone therapy.
  • Known to have acute or chronic active hepatitis B (HBsAg positive and HBV DNA ≥ 200 IU/mL or ≥ 103 copies/mL) or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive).
  • Infected with human immunodeficiency virus (HIV) (HIV 1/2 antibody positive), known to be infected with syphilis.
  • Severe infections that are in the active phase or poorly controlled in clinical practice. Serious infection, including but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia, within 4 weeks prior to the first dose.
  • Significant malnutrition, such as the need for intravenous supplemental nutrient solutions; except for malnutrition corrected more than 4 weeks prior to the first dose.
  • Symptomatic congestive heart failure (New York Heart Association class II-IV); symptomatic or poorly controlled arrhythmias.
  • Uncontrolled arterial hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) even with standard treatment.
  • Any arterial thromboembolic event including myocardial infarction, pulmonary embolism, and unstable angina within 6 months prior to enrollment.
  • A history of deep vein thrombosis or any other serious thromboembolism (implantable IV port or catheter-derived thrombosis, or superficial vein thrombosis is not considered "serious" thromboembolism) within 3 months prior to enrollment.
  • Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh class B or more severe cirrhosis.
  • A history of gastrointestinal perforation and/or fistula in the previous 6 months; a history of peptic ulcer, a history of intestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection complicated by chronic diarrhea), Crohn's disease, ulcerative colitis, abdominal abscess, or long-term chronic diarrhea. Post-intestinal stent implantation.
  • -> 3 loose stools per day at baseline, suggesting a predisposition to colon or small bowel disease with uncontrollable symptoms.
  • A history of allergy or known intolerance to atropine sulfate or loperamide or the appropriate antiemetic in combination with FOLFIRI.
  • Uncontrolled metabolic disorders or other non-malignant organ or systemic diseases or secondary reactions to cancer and can lead to higher medical risk and/or uncertainty in survival evaluation.
  • A known history of inherited bleeding tendency disorders or coagulation disorders.
  • Any life-threatening bleeding event within the previous 3 months, including the need for blood transfusion therapy, surgical or local treatment, or ongoing drug therapy.
  • A high risk of bleeding as determined by the investigators: cirrhosis with severe esophagogastric fundic varices, intermittent or persistent non-fatal bleeding events (including but not limited to intermittent bloody stools or positive occult blood due to primary intestinal lesions, intermittent hemoptysis due to pulmonary metastases).
  • Cerebrovascular accident (including transient ischemic attack) in the previous 6 months.
  • Use of aspirin (>325 mg/day) or other NSAIDs known to inhibit platelet function for 10 consecutive days within 10 days prior to the first dose.
  • Treatment with oral or parenteral anticoagulants or thrombolytics for 10 consecutive days within 10 days prior to the first dose. However, prophylactic use of anticoagulants is allowed.
  • Pleural fluid, ascites, and pericardial effusion with clinical symptoms or requiring drainage, except for small amounts of pleural fluid, small amounts of ascites, and small amounts of pericardial effusion without clinical symptoms on imaging only.
  • A history of other primary malignancies, except: malignancies in complete response for at least 2 years prior to enrollment and requiring no other treatment during the study period; adequately treated non-melanoma skin cancer or malignant freckled nevus with no evidence of disease recurrence; adequately treated carcinoma in situ with no evidence of disease recurrence.
  • A known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Known to be allergic to any monoclonal antibody component.
  • Female subjects in the pregnancy or lactating period.
  • A history of alcohol or drug abuse.
  • Other acute or chronic illnesses, psychiatric disorders, or abnormal laboratory test values that may result in the following outcomes: increasing the risk associated with study participation or study drug administration, or interfering with the interpretation of study results and, at the investigator's discretion, classifying the patient as ineligible for participation in this study.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Li hui, bachelor contact

13600855801 ext. 86

Lihui7701@163.com

About this study

To explore the Efficacy and Safety of Tislelizumab combined with fruquintinib and Chidamide in the treatment of unresectable or advanced microsatellite stabilized (MSS/pMMR) colorectal cancer with liver metastases

Being tested
Tislelizumab, Fruquintinib, Chidamide
Medical subject headings
Colonic Neoplasms

What participants receive

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

  • TislelizumabDrug

    Tislelizumab 200mg，D1, Q3W

  • FruquintinibDrug

    Fruquintinib 3mg ,D1-D14, Q3W

  • ChidamideDrug

    Chidamide 30mg

Study groups in NCT06218888
Study groupRoleWhat they receive
Tislelizumab combined with fruquintinib and ChidamideExperimentalThe treatment option for the chidamide + tislelizumab +fruquibtinib is 200 mg of tislelizumab IV Drip Q3W, 30 mg of chidamide PO BIW, and fruquibtinib 3mg PO Q3W until loss of clinical benefit or development of intolerable toxicity
Receives: Drug: Tislelizumab; Drug: Fruquintinib; Drug: Chidamide

What is being measured

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

  1. Objective Response Rate（ORR）

    The percentage of subjects whose therapeutic effect evaluation is complete response (CR) or partial response (PR) according to RECIST 1.1.

    Measured: Around 2 years

Secondary outcomes (2)

  1. Progression-Free Survival (PFS)

    Time from enrollment to disease progression or death from any cause

    Measured: Around 2 years

  2. Disease Control Rate (DCR)

    The percentage of subjects whose therapeutic effect evaluation is complete response (CR), partial response (PR) or stable disease (SD) according to RECIST 1.1.

    Measured: Around 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 posted23 Jan 2024
  2. Study start1 Jun 2024 (estimated)
  3. Primary completion1 Dec 2025 (estimated)
  4. Study completion1 Dec 2026 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06218888
Sponsor's protocol ID
TFC
Status last verified
Jan 2024
First submitted
12 Jan 2024
Last updated
23 Jan 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab, Fruquintinib and Chidamide in people with Colo-rectal Cancer, run by Fujian Cancer Hospital.

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 11 inclusion and 40 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 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

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 Li hui, bachelor (13600855801 ext. 86, Lihui7701@163.com), 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: Around 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 NCT06218888.

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 23 Jan 2024.

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