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Rectal CancerPhase 2NCT05763927

Neoadjuvant Therapy for Locally Advanced Rectal Cancer With Fruquintinib, Toripalimab and SRT

A Phase 2 study testing Fruquintinib, Toripalimab and Short-course radiotherapy in people with Rectal Cancer, run by West China Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to investigate the efficacy and safety of combined fruquintinib、toripalimab and SRT in neoadjuvant therapy for locally advanced rectal cancer. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rectal Cancer
What is being tested?
Fruquintinib, Toripalimab and Short-course radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
1 siteChina
Study dates
1 Sep 2022to 1 Apr 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Rectal adenocarcinoma was confirmed pathologically;
  • Baseline clinical staging was T3-4 and/or N+, and rectal enhanced MRI was recommended as staging standard;
  • distance from anus ≤12cm;
  • No distant metastasis;
  • Age 18-70, regardless of gender;
  • ECOG(Eastern Cooperative Oncology Group) score ≤1;
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  • No chemotherapy or other anti-tumor therapy was used before inclusion;
  • Major organ functions within 28 days prior to treatment meet the following criteria: A. Blood routine examination criteria (within 14 days without blood transfusion) : Hemoglobin (HB) ≥80g/L, absolute value of neutrophil (ANC) ≥1.5×109/L, absolute value of lymphocytes ≥ the lower limit of normal value, platelet (PLT) ≥80×109/L; B. Biochemical tests should meet the following criteria: Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN; C. Coagulation tests should meet the following standards: International standardized ratio (INR) or prothrombin time (PT) ≤1.5 ULN; Activated partial thrombin time (APTT) ≤1.5 ULN (if the patient is on anticoagulant therapy, as long as PT and APTT are within the expected treatment range); D. Thyroid function: T3 and T4 levels were normal after drug treatment;
  • No history of autoimmune diseases or current autoimmune diseases;
  • Subjects must give informed consent to the study prior to the study and have voluntarily signed a written informed consent;
  • The subjects can communicate well with the researcher and complete the study according to the protocol; Women of reproductive age ;
  • should agree to use contraception (such as an intrauterine device, birth control pill or condom) during the study period and 120 days after the end of the study; Serum or urine pregnancy tests were negative during the 7 days prior to study enrollment.

Who cannot join

  • Patients who have previously received immune checkpoint inhibitors;
  • Known allergic reactions to PD-1 monoclonal antibody active ingredients, TKI inhibitor-related ingredients or any excipients;
  • Patients with organ bleeding or bleeding tendency, except for rectal primary tumor bleeding (need investigator to assess the risk of bleeding;
  • Pregnant or lactating women;
  • years or at the same time have a history of other malignant tumors, but cured skin basal cell carcinoma and cervical carcinoma in situ and thyroid;
  • Patients with uncontrolled epilepsy, central nervous system disease or mental disorders, the investigator judged that their clinical severity may hinder the signing of informed consent or affect the patient 's compliance with oral drugs;
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  • Clinically serious (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or severe arrhythmia requiring drug intervention, or a history of myocardial infarction within the last 12 months;
  • Subjects requiring systemic treatment with corticosteroids (greater than 10 mg prednisone equivalent daily) or other immunosuppressive agents (including organ transplant recipients) within 2 weeks before the first dose of study drug;
  • Participated in other interventional drug clinical trials within 4 weeks before the first dose;
  • Major surgery or severe trauma within 4 weeks before the first dose of study drug;
  • Serious infection (CTCAE greater than grade 2) within 4 weeks before the first dose of study drug,Such as severe pneumonia, bacteremia, infectious complications requiring hospitalization; baseline chest imaging suggests active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first dose of study drug, or the need for oral or intravenous antibiotics (excluding prophylactic antibiotics);
  • Active autoimmune diseases, history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone, using stable doses of insulin type 1 diabetes can be included; but excluding vitiligo or recovered childhood asthma/allergy, without any intervention in adults;
  • History of immunodeficiency, including positive HIV test, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation and bone marrow transplantation;
  • Active pulmonary tuberculosis infection found by medical history or CT examination, Or patients with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or patients with a history of active pulmonary tuberculosis infection but without regular treatment 1 year before enrollment;
  • Subjects with active hepatitis (HBV DNA ≥ 2000 IU/ml or 10000 copies/ml), hepatitis C (hepatitis C antibody positive,HCV-RNA was above the lower limit of detection of the assay);
  • Had a known history of psychotropic drug abuse, alcoholism, or drug use;
  • Had a history, illness, treatment, or laboratory abnormality that could interfere with the results of the trial, prevent the subject from participating throughout the study, or the investigator considered participation to be in the subject 's best interest.

Trial locations and contacts

1 site in 1 country.

Yaqin Zhao, MD contact

18628260828

zhaoyaqin@163.com

China1 site, 1 recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610000

    Zhiping Li, MD, 18980601784, lizhliping620312@163.com

    Recruiting

Other trials in China

About this study

Official title: Prospective Single-arm Phase II Clinical Study of Fruquintinib Combined With Toripalimab and SRT in Neoadjuvant Therapy for Locally Advanced Rectal Cancer

The purpose of this study is to investigate the efficacy and safety of combined fruquintinib、toripalimab and SRT in neoadjuvant therapy for locally advanced rectal cancer.

Read the detailed description

The aim of this study is to investigate whether combined fruquintinib、toripalimab and SRT can achieve breakthrough efficacy in neoadjuvant therapy for locally advanced rectal cancer, achieving a better pCR rate and better tolerance compared with conventional neoadjuvant therapy for locally advanced rectal cancer.

Conditions
Rectal Cancer
Being tested
Fruquintinib, Toripalimab, Short-course radiotherapy, TME
Keywords
Fruquintinib, Toripalimab, SRT, neoadjuvant therapy, pCR
Medical subject headings
Rectal Neoplasms

What participants receive

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

  • FruquintinibDrug

    Fruquintinib 5mg 2w on/1w off, 21d/cycle, totally 4 cycle.

  • ToripalimabDrug

    Toripalimab 200mg d1, 21d/cycle, totally 4 cycle.

  • Short-course radiotherapyRadiation

    Also called SRT

    25 Gy in 5 fraction, d22-26.

  • TMEProcedure or surgery

    Also called Total mesorectal excision

    Surgical resection of the primary tumour in the rectum, 2-4weeks after the last dose of fruquintinib

Study groups in NCT05763927
Study groupRoleWhat they receive
Fruquintinib& Toripalimab& SRTExperimentalInduction treatment: Fruquintinib 5mg d1-d14； Toripalimab 240 mg intravenously d1； Consolidation treatment: SRT: 25 Gy in 5 fractions d22-d26； Fruquitinib 5mg d22-d35，43-56,64-77； Toripalimab 240 mg intravenously d22、43、64； Surgery: Surgical resection will be performed according to the principles of TME(total mesorectal excision) 2-4 weeks after the last dose administration of Fruquintinib； Adjuvant chemotherapy: Standard chemotherapy or observation according to the judgement of Principle Investigator and patients' willing.
Receives: Drug: Fruquintinib; Drug: Toripalimab; Radiation: Short-course radiotherapy; Procedure: TME

What is being measured

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

  1. pCR following neoadjuvant chemotherapy

    Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells)

    Measured: approximately 2 weeks after the resection of primary lesion

Secondary outcomes (4)

  1. R0 resection rate

    number of R0 surgery divide all participants (44pts)

    Measured: approximately 2 weeks after the resection of primary lesion

  2. Objective response rate

    Objective tumour response (ORR) will is defined as the proportion of subjects who achieve a partial or complete response according to RECIST criteria version 1.1

    Measured: approximately before the resection of primary lesion

  3. 1 year DFS(disease free survival) rate

    evaluate the 1-year DFS rate after the resection of primary lesion（only patients who acquire R0 resection）

    Measured: 1 year

  4. 1 year OS(overall survival) rate

    evaluate the 1-year OS rate after the neoadjuvant therapy

    Measured: 1 year

Timeline

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

  1. First posted10 Mar 2023
  2. Study start1 Sep 2022
  3. Primary completion1 Oct 2024 (estimated)
  4. Study completion1 Apr 2025 (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
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05763927
Sponsor's protocol ID
2021-013-CH11 IIT-CR
Status last verified
Mar 2023
First submitted
27 Feb 2023
Last updated
10 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: IPD(individual patient data) Sharing Plan: Shared for: scientific research institutions, academic journal editors, government agencies Sharing conditions: IPD sharing shall meet the following conditions: Requestor must provide study agreement and relevant ethical review committee approval documents Requestor must ensure legality of data use and privacy protection Requestor must agree to data sharing, and the study team has the right to review the Requestor 's study plan and provide necessary support and interpretation of data Scope of shared data: The shared data includes ECG and clinical data of all subjects, but excluding personal information of subjects

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fruquintinib, Toripalimab and Short-course radiotherapy in people with Rectal Cancer, run by West China 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 12 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 10 Mar 2023. 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 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?

Results are not available in the source record.

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

Contact Yaqin Zhao, MD (18628260828, zhaoyaqin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pCR following neoadjuvant chemotherapy (time frame: approximately 2 weeks after the resection of primary lesion). 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 NCT05763927.

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 10 Mar 2023.

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