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Advanced Microsatellite Stable Colorectal CancerPhase 2NCT04724239

Sintilimab and Chidamide in Combination With or Without IBI305 in Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

A Phase 2 study testing Sintilimab, Chidamide and IBI305 in people with Advanced Microsatellite Stable Colorectal Cancer and Metastatic Microsatellite-stable Colorectal Cancer, run by Sun Yat-sen University 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 The sponsor has not verified this record for over two years, so it may be out of date.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 evaluate the efficacy and safety of sintilimab and chidamide in combination with or without IBI305(bevacizumab) in patients with standard treatment failure of advanced or metastatic pMMR/MSS colorectal adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Sintilimab, Chidamide and IBI305
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteChina
Study dates
11 Mar 2021to Dec 2023
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

  • Histologically confirmed diagnosis of unresectable locally advanced, recurrent or metastatic colorectal adenocarcinoma.
  • Tumor tissues were identified as mismatch repair-proficient (pMMR) by immunohistochemistry (IHC) method or microsatellite stability (MSS) by polymerase chain reaction (PCR).
  • Subjects must have failed at least two lines of prior treatment.
  • Subjects must have one measurable lesion according to RECIST v1.1 at least.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • 18-75 years old.
  • Life expectancy of at least 12 weeks.
  • Adequate bone marrow, liver, renal and coagulation function as assessed by the laboratory required by protocol

Who cannot join

  • Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody or histone deacetylase (HDAC) inhibitor.
  • Received last dose of anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) within 3 weeks of the first dose of study medication.
  • Received radiotherapy with 4 weeks of the first dose of study medication.
  • Underwent major operation within 4 weeks of the first dose of study medication or open wound, ulcer or fracture.
  • Known symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Subjects received prior treatment and have stable disease more than 4 weeks from first dose of study medication are permitted to enroll.
  • Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years.
Show all 15Show fewer
  • Interstitial lung disease requiring corticosteroids.
  • Active or poorly controlled serious infections.
  • Significant malnutrition.
  • Symptomatic congestive heart failure (NYHA Class II-IV) or symptomatic or poorly controlled arrhythmia.
  • Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) despite standard treatment.
  • Within 6 months prior to the enrollment, history of gastrointestinal perforation and/or fistula, gastrointestinal ulcer, bowel obstruction, extensive bowel resection, Crohn's disease, or ulcerative colitis, intra-abdominal abscesses, or long-term chronic diarrhea.
  • History or evidence of inherited bleeding diathesis or coagulopathy or thrombus
  • Any life-threatening bleeding within 3 months prior to the enrollment.
  • High risk of bleeding.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer center of Sun Yat-sen University

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: A Randomized Phase 2 Clinical Trial Evaluating Sintilimab and Chidamide in Combination With or Without IBI305 in Patients With Standard Treatment Failure of Advanced or Metastatic pMMR/MSS Colorectal Carcinoma

The purpose of this study is to evaluate the efficacy and safety of sintilimab and chidamide in combination with or without IBI305(bevacizumab) in patients with standard treatment failure of advanced or metastatic pMMR/MSS colorectal adenocarcinoma.

Read the detailed description

In this study, we explored the potential effectiveness of combining PD-1 monoclonal antibody sintilimab with the histone deacetylase inhibitor (HDACi) chidamide, with or without IBI305(bevacizumab), in MSS/pMMR unresectable locally advanced or metastatic colorectal cancer patients who failed standard chemotherapy and testified this new combination in preclinical models. Fourty-eight patients were randomized into two groups: the doublet group, who received sintilimab 200 mg every 3 weeks and chidamide 30 mg orally twice weekly, and the triplet group, who received sintilimab, chidamide, and bevacizumab 7.5 mg/kg every 3 weeks.

Being tested
Sintilimab, Chidamide, IBI305
Keywords
Colorectal Carcinoma, pMMR, Microsatellite-stable
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • SintilimabDrug

    200mg IV on Day 1 Q3W

  • ChidamideDrug

    30mg PO BIW each 3-week cycle

  • IBI305Drug

    Also called Bevacizumab

    7.5mg/kg IV on Day 1 Q3W

Study groups in NCT04724239
Study groupRoleWhat they receive
The triplet group (sintilimab + chidamide + IBI305)ExperimentalEvery 3 weeks, patients received sintilimab 200 mg and IBI305(bevacizumab) 7.5 mg/kg on day one and chidamide 30 mg orally twice weekly.
Receives: Drug: Sintilimab; Drug: Chidamide; Drug: IBI305
The doublet group (sintilimab + chidamide)Active comparatorEvery 3 weeks, patients received sintilimab 200 mg on day one and chidamide 30 mg orally twice weekly.
Receives: Drug: Sintilimab; Drug: Chidamide

What is being measured

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

  1. The progression-free survival (PFS) rates at 18 weeks

    The proportion of patients without disease progression or death at the 18th week after initiation of the study treatment

    Measured: 24 months

Secondary outcomes (5)

  1. Objective response rate (ORR)

    The proportion of patients with a PR or CR

    Measured: 2 year

  2. Progression-free survival (PFS);

    The time from enrollment until tumor progression or death from any cause, whichever occurred first

    Measured: 2 year

  3. Overall Survival (OS);

    The time calculated from enrollment until death from any cause, with living patients censored at the last known survival date

    Measured: 2 year

  4. Disease control rate (DCR)

    The proportion of patients with a PR, CR, or SD

    Measured: 2 year

  5. Duration of response (DoR)

    For patients who achieved a complete response (CR) or partial response (PR), the time from the first tumor assessment demonstrating response until disease progression or death, whichever occurred first

    Measured: 2 year

Timeline

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

  1. First posted26 Jan 2021
  2. Study start11 Mar 2021
  3. Primary completion26 Jul 2022
  4. Study completionDec 2023 (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
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized in approximately a 1:1 ratio to receive sintilimab and chidamide with or without IBI305.
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04724239
Sponsor's protocol ID
CAPability-01
Status last verified
Jul 2023
First submitted
25 Jan 2021
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wang F, Jin Y, Wang M, Luo HY, Fang WJ, Wang YN, Chen YX, Huang RJ, Guan WL, Li JB, Li YH, Wang FH, Hu XH, Zhang YQ, Qiu MZ, Liu LL, Wang ZX, Ren C, Wang DS, Zhang DS, Wang ZQ, Liao WT, Tian L, Zhao Q, Xu RH. Combined anti-PD-1, HDAC inhibitor and anti-VEGF for MSS/pMMR colorectal cancer: a randomized phase 2 trial. Nat Med. 2024 Apr;30(4):1035-1043. doi: 10.1038/s41591-024-02813-1. Epub 2024 Mar 4.

    PubMed 38438735

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sintilimab, Chidamide and IBI305 in people with Advanced Microsatellite Stable Colorectal Cancer and Metastatic Microsatellite-stable Colorectal Cancer, run by Sun Yat-sen University 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 8 inclusion and 15 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 1 Aug 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?

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?

The progression-free survival (PFS) rates at 18 weeks (time frame: 24 months). 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 NCT04724239, which also lists 1 linked publication.

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 2023.

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