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Metastatic Colorectal CancerPhase 2NCT05690035

Tislelizumab Combined With Fruquintinib for Metastatic pMMR/MSS Colorectal Cancer

A Phase 2 study testing Tislelizumab & Fruquintinib in people with Metastatic Colorectal Cancer and mCRC, run by Sun Yat-sen University at 2 sites in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is an open-label phase II study, with the aim of investigating the efficacy and safety of Tislelizumab + Fruquintinib combination therapy in ARID1A-mutated pMMR/MSS metastatic colorectal cancer who have been treated with standard chemotherapy that includes fluoropyrimidine, oxaliplatin, and irinotecan. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Metastatic Colorectal Cancer, mCRC
What is being tested?
Tislelizumab & Fruquintinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
2 sitesChina
Study dates
Jul 2025to Jul 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-80 years old (including 18 and 80);
  • Histologically confirmed colorectal adenocarcinoma and biopsy pathology confirmed MSS/pMMR;
  • Gene testing confirmed ARID1A gene mutation (nonsynonymous);
  • No signs of intestinal obstruction; Or intestinal obstruction has been relieved after proximal colostomy;
  • Has received and failed ≥ 2 line of chemotherapy or progressed on or intolerable to oxaliplatin, irinotecan and fluorouracil chemotherapy after diagnosed with mCRC;
  • ECOG PS 0-2;
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  • Able to swallow tablets;
  • Life expectancy of greater than 3 months;
  • Adequate bone marrow and organ function;
  • If female and of childbearing potential, must:
  • Have a negative pregnancy test ≤14 days prior to initiating study treatment
  • Agree to avoid pregnancy during and for 3 months after study treatment
  • If male with a partner of childbearing potential, must:
  • Agree to use adequate, medically approved, contraceptive precautions during and for 3 months after the last dose of study treatment.
  • Able and willing to provide written informed consent for the study.

Who cannot join

  • Any active autoimmune disease or history of autoimmune disease;
  • Those who are using immunosuppressive agents, or systemic or absorbable local hormone therapy to achieve immunosuppressive purpose, and continue to use within 2 weeks before enrollment;
  • Severe allergic reaction to other monoclonal antibodies;
  • Subjects with clinical symptoms of untreated active brain metastasis or meningeal metastasis;
  • Have received other PD-1 antibody therapy or other immunotherapy targeting PD-1/PD-L1 in the past;
  • Patients with high TMB (≥ 30Muts/Mb) and germline or somatic POLE/POLD1 gene mutations in the exonuclease domain;
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  • There are clinical symptoms or diseases of heart that are not well controlled, such as: (a) heart failure of NYHA level 2 or above (b) unstable angina pectoris (c) myocardial infarction occurred within 1 year (d) clinically significant supraventricular or ventricular arrhythmia needs treatment or intervention;
  • Known hereditary or acquired bleeding and thrombophilia or being treated with thrombolysis or anticoagulation;
  • Urinary protein ≥ ++, or the 24-hour urine protein quantification greater than 1.0g;
  • Clinically significant bleeding symptoms or clear bleeding tendency within 3 months before enrollment;
  • Subjects with active infection;
  • Congenital or acquired immune deficiency (such as HIV infected persons), or active hepatitis (hepatitis B: HBsAg positive and HBV DNA ≥ 10^4 copies/ml; hepatitis C: HCV antibody positive);
  • Other advanced malignant tumors within 5 years (except cured skin basal cell carcinoma, cervical carcinoma in situ, ovarian cancer, thyroid cancer and breast cancer);
  • Live vaccine may be inoculated less than 4 weeks before the study medication or during the study period;
  • Known or suspected to be allergic to the study drug or to any drug given in this trial;
  • Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions that makes the subject not eligible according to the judgment of the investigator.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Sun Yat-sen University, Cancer Center

    Guangzhou, Guangdong, 510060

  • Xiaoshi Zhang

    Guangzhou

Other trials in China

About this study

Official title: PD-1 Antibody (Tislelizumab) Combined With VEGFR 1/2/3 Inhibitor (Fruquintinib) for ARID1A-mutated Metastatic pMMR/MSS Colorectal Cancer: an Open-label, Multi-center, Phase II Clinical Trial

This is an open-label phase II study, with the aim of investigating the efficacy and safety of Tislelizumab + Fruquintinib combination therapy in ARID1A-mutated pMMR/MSS metastatic colorectal cancer who have been treated with standard chemotherapy that includes fluoropyrimidine, oxaliplatin, and irinotecan. Patients with hypermutated CRC that carries POLE/POLD1 mutations cannot be included.

Read the detailed description

In this open-label phase II study, patients with ARID1A-mutated pMMR/MSS metastatic colorectal cancer who have been treated with standard chemotherapy that includes fluoropyrimidine, oxaliplatin, and irinotecan, will be scheduled for Tislelizumab (200mg ivdrip Q3W day1) + Fruquintinib (5mg/day Q3W day1-14) until intolerable toxicity, disease progression or death. Primary endpoint of this study is ORR and secondary endpoints are OS, PFS, DCR and safety.

Being tested
Tislelizumab & Fruquintinib
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Tislelizumab & FruquintinibDrug

    combinational treatment of Tislelizumab and Fruquintinib until PD, intolerable toxicity, death or withdrawal of informed consent

Study groups in NCT05690035
Study groupRoleWhat they receive
patients with mCRCExperimentalTislelizumab 200mg ivdrip every 3 weeks; Fruquintinib 5mg qd day 1-14, every 3 weeks
Receives: Drug: Tislelizumab & Fruquintinib

What is being measured

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

  1. Objective Response Rate (ORR)

    The proportion of patients with a confirmed complete response or partial response

    Measured: up to 3 years

Secondary outcomes (4)

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from enrollment to the first documented progressive disease (PD) or death due to any cause, whichever occurred first.

    Measured: up to 3 years

  2. Overall Survival (OS)

    OS is defined as the time from enrollment to death due to any cause.

    Measured: up to 3 years

  3. Disease control rate

    The proportion of patients with a best overall response of confirmed complete or partial response, or stable disease (CR+ PR + SD).

    Measured: up to 3 years

  4. Incidence of Treatment-Emergent Adverse Events

    Safety and tolerance evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0.

    Measured: until 60 days after last patient last study drug treatment

Timeline

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

  1. First posted19 Jan 2023
  2. Study startJul 2025 (estimated)
  3. Primary completionJul 2025 (estimated)
  4. Study completionJul 2025 (estimated)

Why it stopped: Due to slow patient recruiting. No patients were enrolled 12 months after study initiation.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05690035
Sponsor's protocol ID
SL-B2022-653-01
Status last verified
Jul 2024
First submitted
10 Jan 2023
Last updated
9 Jul 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tislelizumab & Fruquintinib in people with Metastatic Colorectal Cancer and mCRC, run by Sun Yat-sen 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 15 inclusion and 16 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: withdrawn, as of the sponsor's last update on 9 Jul 2024. 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 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?

The study was withdrawn before enrolling participants, so there are no results.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: up to 3 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 NCT05690035.

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 9 Jul 2024.

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