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Colorectal CancerPhase 2NCT05371197

Envafolimab as Neoadjuvant Immuntherapy in Resectable Local Advanced dMMR/MSI-H Colorectal Cancer

A Phase 2 study testing Neoadjuvant therapy with PD-L1 inhibitor in people with Colorectal Cancer and Mismatch Repair-deficient (dMMR), run by Third Affiliated Hospital, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Colorectal cancer (CRC) is one of the most common malignant tumours of human beings. Mismatch Repair-deficient (dMMR)/ Microsatellite Instability-high (MSI-H) CRC is a specific subtype of CRC, which accounts for approximately 15% of all CRC patients, and can not benefit from 5-fluorouracil (5-FU) adjuvant… Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Neoadjuvant therapy with PD-L1 inhibitor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteChina
Study dates
5 May 2022to 31 Dec 2024
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent.
  • Histological or cytological documentation of adenocarcinoma of the colon or rectum.
  • Tumor tissues were identified as mismatch repair-deficient (dMMR) by immunohistochemistry (IHC) method or microsatellite instability-high (MSI-H) by polymerase chain reaction (PCR).
  • Male or female subjects > 18 years < 70 of age.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Determined CT or MRI scans (done within 14 days of registration) of the chest, abdomen and pelvis: locally advanced (cT3-4 or cN1-2 [with the definition of a clinically positive lymph node being any node ≥ 1.0 cm]).
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  • Non complicated primary tumor (obstruction, perforation, bleeding).
  • No previous any systemic anticancer therapy for colorectal cancer disease or radiologic evaluation of tumor regression < 20% or unacceptable toxic effects during neoadjuvant chemotherapy.
  • Adequate bone marrow, hepatic and renal function as assessed by the following laboratory requirements conducted within 7 days of starting study treatment.

Who cannot join

  • Previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization.
  • Significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment.
  • Heart failure grade III/IV (NYHA-classification).
  • Unresolved toxicity higher than CTCAE v.4.0 Grade 1 attributed to any prior therapy/procedure.
  • Subjects with known allergy to the study drugs or to any of its excipients.
  • Current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study.
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  • Breast- feeding or pregnant women
  • Lack of effective contraception.
  • Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody, anti-cytotoxic T lymphocyte-associated antigen 4 (cytotoxic T-lymphocyte-associated Protein 4, CTLA-4) antibody or other drug/antibody that acts on T cell costimulation or checkpoint pathways.
  • With any distant metastasis.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • the Third Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, 510630

    Jiafeng Fang, M.D. & Ph.D., +8613760660785, fangjf@mail.sysu.edu.cn

    Jiafeng Fang, M.D. & Ph.D.

    Recruiting

Other trials in China

About this study

Colorectal cancer (CRC) is one of the most common malignant tumours of human beings. Mismatch Repair-deficient (dMMR)/ Microsatellite Instability-high (MSI-H) CRC is a specific subtype of CRC, which accounts for approximately 15% of all CRC patients, and can not benefit from 5-fluorouracil (5-FU) adjuvant chemotherapy. Once patients have distant metastases, they are not sensitive to traditional palliative chemotherapy, and thus lead to much worse prognosis than that of mismatch repair-proficient (pMMR)/ microsatellite stability (MSS). A phase II clinical study of anti-PD-1 immunotherapy based on mismatch repair (MMR) status published in "N Engl J Med" showed that the objective response rate (ORR) of advanced colorectal cancer patients with dMMR received anti-PD-1 is 40%, and a longer response time can be obtained compared to conventional chemotherapy. Another study (ClinicalTrials.gov, NCT03926338) which investigating the effect of neoadjuvant PD-1 blockade with toripalimab, with or without celecoxib, on mismatch repair-deficient or microsatellite instability-high, locally advanced, colorectal cancer. The result revealed that all 34 patients had an R0 resection. 15 of 17 patients (88%) in the toripalimab plus celecoxib group and 11 of 17 patients (65%) in the toripalimab monotherapy group had a pathological complete response.

In theory, anti-PD-L1 drugs should have fewer immune side-effects than anti-PD-1 drugs. However, there are no reports of anti-PD-L1 neoadjuvant therapy for the dMMR/MSI-H colorectal cancer. Therefore, the aim of this study was to investigate the efficacy and safety of anti-PD-L1 monoclonal antibody (Envafolimab) as neoadjuvant immuntherapy for resectable local advanced colorectal cancer patient with the dMMR/MSI-H.

Being tested
Neoadjuvant therapy with PD-L1 inhibitor
Medical subject headings
Colorectal Neoplasms, Turcot syndrome

What participants receive

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

  • Neoadjuvant therapy with PD-L1 inhibitorDrug

    Neoadjuvant therapy with PD-L1 inhibitor (Envafolimab), 300mg, Q3W for 4 cycles

Study groups in NCT05371197
Study groupRoleWhat they receive
PD-L1 inhibitorExperimentalNeoadjuvant therapy with PD-L1 inhibitor (Envafolimab)
Receives: Drug: Neoadjuvant therapy with PD-L1 inhibitor

What is being measured

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

  1. Pathological complete response (pCR) rates

    Proportion of patients experiencing a pCR to perioperative PD-L1 antibody

    Measured: 1 year

Secondary outcomes (6)

  1. Major pathological response rates

    The proportion of patients experiencing a major pathological response to perioperative PD-L1 antibody

    Measured: 1 year

  2. R0 resection rates

    The proportion of patients experiencing a R0 resection after perioperative treatment with PD-L1 antibody

    Measured: 1 year

  3. Disease-free survival (DFS)

    Defined as the time from randomization to relapse, metastasis or death from any cause

    Measured: 3 years

  4. Overall survival (OS)

    Defined as the time from randomization to death from any cause

    Measured: 5 years

  5. Drug Safety

    Assessed by evaluation of treatment-related adverse events

    Measured: 1 year

  6. Drug feasibility

    Any treatment-related delays in the planned surgery of no more than 28 days after the last preoperative toripalimab dose

    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 posted12 May 2022
  2. Study start5 May 2022
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion31 Dec 2024 (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
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05371197
Sponsor's protocol ID
ENCC
Status last verified
May 2022
First submitted
29 Nov 2021
Last updated
12 May 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neoadjuvant therapy with PD-L1 inhibitor in people with Colorectal Cancer and Mismatch Repair-deficient (dMMR), run by Third Affiliated Hospital, 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 9 inclusion and 10 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 12 May 2022. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rates (time frame: 1 year). 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 NCT05371197.

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 12 May 2022.

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