AzTrials
AzTrials

Colorectal CancerPhase 1/2NCT07491159

Fruquintinib Plus Checkpoint Inhibitor Combined or Sequential TAS-102 in Colorectal Cancer Patients Who Progressed on Second-line Standard Therapy: a Prospective, Multi-cohort, Single-centered, Phase Ib/II Study

A Phase 1/2 study testing Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil and Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab in people with Colorectal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Colorectal cancer (CRC) is the fourth leading cause of cancer death worldwide, claiming approximately 900,000 lives annually. In China, CRC has become one of the top three most common cancers, with about 555,000 new cases and 286,000 deaths reported in 2020. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil and Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
106 participants
Where
1 siteChina
Study dates
1 Jul 2023to 30 Dec 2026
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fully informed about this study and voluntarily signed the informed consent form;
  • Age 18-75 years (inclusive);
  • Histologically confirmed unresectable metastatic colorectal cancer;
  • Confirmed pMMR (proficient mismatch repair) status without protein loss, as determined by:PCR testing showing microsatellite stable (MSS) or low microsatellite instability (MSI-L), OR Immunohistochemistry (IHC) demonstrating intact DNA mismatch repair (MMR) protein expression (including MLH1, MSH2, MSH6, and PMS2);
  • Failed or intolerant to two prior lines of standard systemic therapy for metastatic colorectal cancer;
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
Show all 16Show fewer
  • Body Mass Index (BMI) ≥18 kg/m²;
  • Life expectancy ≥3 months;
  • Adequate organ function as defined below (no blood components or growth factors allowed within 14 days prior to enrollment):
  • Hematologic Function:
  • Absolute neutrophil count (ANC) ≥1.5×10⁹/L; White blood cell count (WBC) ≥4.0×10⁹/L; Platelet count ≥100×10⁹/L; Hemoglobin ≥90 g/L; -Hepatic Function: Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5×ULN;
  • -Renal Function: Blood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN; Creatinine clearance (CCr) ≥50 mL/min;
  • -Cardiac Function: Left ventricular ejection fraction (LVEF) ≥50%; QT interval corrected by Fridericia's formula (QTcF) <470 ms;
  • -Coagulation Function: International normalized ratio (INR) ≤1.5×ULN; Activated partial thromboplastin time (APTT) ≤1.5×ULN;
  • Women of childbearing potential must use effective contraception;
  • Good compliance and willing to cooperate with follow-up visits.

Who cannot join

  • Unable to comply with the study protocol or study procedures;
  • Prior treatment with TAS-102 (trifluridine/tipiracil);
  • Prior treatment with VEGFR inhibitors;
  • Prior treatment with immune checkpoint inhibitors;
  • Concurrent use of any other investigational drugs, or participation in another clinical trial with investigational drug treatment within 4 weeks prior to enrollment;
  • Vaccination with inactivated vaccines within 4 weeks prior to enrollment or planned vaccination during the study period;
Show all 28Show fewer
  • Major surgery, severe traumatic injury, fracture, or ulcer within 4 weeks prior to enrollment;
  • Blood transfusion, blood products, or hematopoietic factors (such as albumin, granulocyte colony-stimulating factor [G-CSF], etc.) within 28 days prior to enrollment;
  • Alcohol or drug abuse within 4 weeks prior to enrollment;
  • Any factors affecting oral drug administration;
  • Concurrent presence of any of the following conditions:
  • Uncontrolled hypertension, coronary artery disease, arrhythmia, or heart failure;
  • Uncontrolled severe concurrent infection resulting in disability;
  • Proteinuria ≥2+ (1.0 g/24 h);
  • Evidence or history of bleeding tendency within 2 months prior to enrollment, regardless of severity;
  • Arterial/venous thromboembolic events within 12 months prior to first treatment, such as cerebrovascular accident (including transient ischemic attack), etc.;
  • Acute myocardial infarction, acute coronary syndrome, or coronary artery bypass grafting (CABG) within 6 months prior to first treatment;
  • Fracture or long-term unhealed wounds;
  • Coagulation dysfunction, bleeding tendency, or currently receiving anticoagulant therapy;
  • Evidence of central nervous system (CNS) metastasis, or accompanied by severe malignant pleural effusion or ascites;
  • Other malignancies within 5 years prior to enrollment, except for basal cell or squamous cell carcinoma of the skin after curative surgery, or carcinoma in situ of the cervix;
  • Active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
  • Prior allogeneic bone marrow transplantation or organ transplantation;
  • Known hypersensitivity to study drugs or any of their excipients;
  • Unresolved toxicities greater than CTCAE v5.0 Grade 1 from prior anti-cancer therapy, excluding alopecia, lymphopenia, and oxaliplatin-induced neurotoxicity ≤Grade 2;
  • Any other disease, clinically significant metabolic abnormality, physical examination abnormality, or laboratory abnormality that, in the investigator's judgment, provides reasonable suspicion that the patient has a condition unsuitable for the use of the study drug (e.g., epileptic seizures requiring treatment), or that would affect the interpretation of study results, or would place the patient at high risk;
  • Pregnant or breastfeeding women;
  • Any patient deemed unsuitable for enrollment in this study by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality, 300202

Other trials in China

About this study

Official title: Fruquintinib Plus Checkpoint Inhibitor Combined or Sequential Trifluridine/Tipiracil(TAS-102) Based Regimen in Colorectal Cancer Patients Who Progressed on Second-line Standard Therapy: a Prospective, Multi-cohort, Single-centered, Phase Ib/II Study

Colorectal cancer (CRC) is the fourth leading cause of cancer death worldwide, claiming approximately 900,000 lives annually. In China, CRC has become one of the top three most common cancers, with about 555,000 new cases and 286,000 deaths reported in 2020.

For patients with advanced metastatic colorectal cancer (mCRC), chemotherapy remains the main treatment approach. While first and second-line treatments have improved survival rates, treatment options become very limited after these initial therapies fail.

Read more

Current third-line options include single-drug treatments with fruquintinib, regorafenib, or Trifluridine/Tipiracil(TAS-102). Although these medications can extend survival, their effectiveness still needs improvement.

Additionally, approximately 95% of mCRC patients have a tumor type [Proficient Mismatch Repair(pMMR)/Microsatellite Stable(MSS)] that responds poorly to immunotherapy alone, making it crucial to find ways to expand the benefits of immunotherapy to more patients.

This study aims to evaluate the effectiveness and safety of combining:

Fruquintinib (a targeted therapy) Immune checkpoint inhibitors (immunotherapy) TAS-102 (oral chemotherapy)in patients with unresectable metastatic colorectal cancer who have failed standard second-line treatments.

By exploring combination therapy strategies, this research hopes to improve treatment response rates, extend overall survival and provide new treatment options for patients with limited choices

Being tested
Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil, Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab
Keywords
fruquintinib, Trifluridine/tipiracil, Microsatellite Stable, metastatic colorectal cancer
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracilDrug

    Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil

  • Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumabDrug

    Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab

Study groups in NCT07491159
Study groupRoleWhat they receive
Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracilExperimentalFruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil
Receives: Drug: Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil
Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumabExperimentalFruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab
Receives: Drug: Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab

What is being measured

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

  1. RP2D

    Recommended phase 2 dose

    Measured: From enrollment to the end of treatment at 4 week

  2. Overall Survival (OS)

    Time from randomization/enrollment to death from any cause

    Measured: Up to 36 months

Secondary outcomes (6)

  1. Progress-free Survival (PFS)

    Time from randomization/enrollment to first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first

    Measured: Assessed every 8 weeks, up to 12 months

  2. Objective Response Rate (ORR)

    The proportion of patients who achieve a confirmed complete response (CR) or partial response (PR) as their best overall response, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Tumor assessments performed at baseline, then every 8 weeks (±7 days) from the date of first dose until radiographic disease progression or death, assessed up to approximately 12 months

  3. Duration of Response (DoR)

    Time from first documented response (CR/PR) to disease progression or death

    Measured: Up to 12 months

  4. Incidence of AEs

    Number and percentage of participants experiencing adverse events graded by NCI-CTCAE v5.0

    Measured: by NCI-CTCAE v5.0. From first dose up to 30 days after last dose

  5. Incidence of SAEs

    Number and percentage of participants experiencing serious adverse events

    Measured: From informed consent up to 30 days after last dose

  6. Number of participants with Laboratory abnormalities

    Incidence of clinically significant laboratory parameter changes per NCI-CTCAE v5.0

    Measured: From baseline up to 30 days after last dose

Timeline

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

  1. First posted24 Mar 2026
  2. Study start1 Jul 2023
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion30 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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
106 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07491159
Sponsor's protocol ID
CRC later-line
Status last verified
Jul 2025
First submitted
26 Feb 2026
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Informed consent limitations: Original consent may not have covered IPD sharing with external researchers

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Fruquintinib plus immunocheckpoint inhibitor plus trifluridine/tipiracil and Fruquintinib plus immunocheckpoint inhibitor followed by trifluridine/tipiracil plus bevacizumab in people with Colorectal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site 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 16 inclusion and 28 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: under way, not looking for participants, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

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?

RP2D (time frame: From enrollment to the end of treatment at 4 week). The study lists 2 primary outcomes in all. 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 NCT07491159.

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 24 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in