ClinicalTrials.gg
CompletedNCT04482608Updated Jul 27, 2020

The mCRC Patients With pMMR/MSS or dMMR/MSI-H Status Received Palliative Chemotherapy Efficacy and Survival

An observational study in Colorectal Cancer Metastatic, Mismatch Repair Deficiency and Microsatellite Instability High, sponsored by Sun Yat-sen University. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-07-27.

Sponsored by Sun Yat-sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
671
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 12 studies in Turcot syndrome with a site in China — 7 open to participants now, 10 under way, none of them phase 3. Turcot syndrome · China.

Started
2019
with 1 other
Observational
Only one
of the 12
Registered
2nd of 12
by date
Lead sponsor
4 of 12
Sun Yat-sen University

Among the 12 studies in Turcot syndrome with a site in China, this one is one of 2 that started in 2019, is the only observational one, and was the 2nd registered.

Turcot syndrome

60 studies on the registry are indexed under Turcot syndrome; 29 are open to participants now.

Browse Turcot syndrome studies →

Open to participants now

7 of the 12 studies in Turcot syndrome with a site in China are open now. Recruiting first, the newest first:

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All 7 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 19 Turcot syndrome studies recruiting now, 16 (84%) set no upper age limit and 2 (11%) stop at 75 or younger; 3 take children under 18; 1 takes healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 12 studies in Turcot syndrome with a site in China, or all of them as a file.
02

Study summary

Deficient mismatch repair (dMMR) or microsatellite instability high (MSI-H) accounts for 4-5% in metastatic colorectal cancer (mCRC). The efficacy and survival of patients with dMMR/MSI-H status received palliative chemotherapy have not clear yet. In this study, the investigators observed the efficacy and survival of dMMR/MSI-H status mCRC patients received palliative first-line chemotherapy.

Read the detailed description

Colorectal cancer (CRC) is the one of most common cancer in the world. Loss of function of DNA mismatch repair (MMR) is an important mechanism of CRC development. Mutation or modification of MMR genes result in MMR protein deficient (dMMR) and microsatellite instability (MSI). It has been reported that the dMMR or MSI high (MSI-H) phenotype is present in approximately 15-18% of CRC patients. Most dMMR/MSI-H tumors are sporadic CRC, and only approximately 3% of dMMR/MSI-H tumors are Lynch syndrome (LS) or hereditary nonpolyposis colorectal carcinoma (HNPCC).

The dMMR/MSI-H status was reported to be a predictive marker for adjuvant chemotherapy. Multiple retrospective studies showed that dMMR/MSI-H is correlated with a favorable prognosis in stage II/III CRC. Previous studies suggested that dMMR/MSI status may be a predictive marker of decreased benefit form adjuvant monotherapy of 5-fluorouracil (5-FU) in patients with stage II disease, but not in those with stage III disease. For metastatic colorectal cancer (mCRC), the relationship of the MMR/MSI phenotype and prognosis is unclear. Some researchers found that CRC patients with the dMMR/MSI-H phenotype have a worse prognosis. But other researchers thought the dMMR/MSI-H phenotype is no associate to efficacy and survival of palliative chemotherapy, even is benefit for efficacy and survival.Therefore, the aim of this study was to clarify whether the status of dMMR/MSI-H affected progression-free survival (PFS) in mCRC patients who received first-line palliative chemotherapy.

03

Conditions studied

  • Colorectal Cancer Metastatic
  • Mismatch Repair Deficiency
  • Microsatellite Instability High

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Keywords

  • Colorectal Cancer Metastatic
  • Mismatch Repair Deficiency
  • Microsatellite Instability High
  • Chemotherapy
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The metastatic colorectal patients with different MMR or microsatellite status received palliative chemotherapy

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age ≥ 18 years old
  2. confirmed colorectal adenocarcinoma;
  3. Immunohistochemistry confirmed mismatch repair status or polymerase chain reaction (pCR) / next-generation sequencing (NGS) confirmed microsatellite status
  4. Received palliative chemotherapy and have complete information of treatment

Exclusion criteria

Exclusion Criteria:

  1. Patients have not tested for mismatch repair or microsatellite
  2. Patients have not received palliative chemotherapy or received palliative chemotherapy but treatment information incomplete
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
671 participants (actual)
Patient registry
No

Groups and cohorts

  • pMMR/MSS mCRC patients

    The metastatic colorectal cancer patients with proficient mismatch repair or microsatellite stable status.

  • dMMR/MSI-H mCRC patients

    The metastatic colorectal cancer patients with deficient mismatch repair or microsatellite instability high status.

06

What researchers measure

Primary outcomes

  1. Progression-Free Survival (PFS)

    PFS as measured in accordance with the Response Evaluation Criteria In Solid Tumours (RECIST) version 1.1

    Time frame: up to 24-36 months

Secondary outcomes

  1. Response rate

    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

    Time frame: From first patient first visit to 6 month after last patient first visit

  2. Disease Control Rate (DCR)

    Based on Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)

    Time frame: From first patient first visit to 6 month after last patient first visit

  3. Overall survival

    The time from registration to death due to any cause, or censored at date last known alive.

    Time frame: up to approximately 9 year

07

Study locations

1 site
  • Sun yat-sen university cancer center
    Guangzhou, Guangdong 510060, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2019 to primary completion in Apr 2020, 7 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 18, 2020
First posted
Jul 22, 2020
StartActual
Sep 1, 2019
Primary completionActual
Apr 1, 2020
CompletionActual
Jun 8, 2020
Last update
Jul 27, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04482608
Collaborators
The Second Affiliated Hospital of Kunming Medical University
Responsible party
Ruihua Xu (Clinical Professor, Sun Yat-sen University) — Principal investigator
First posted
Jul 22, 2020
Start date
Sep 1, 2019
Primary completion
Apr 1, 2020
Completion
Jun 8, 2020
Last update
Jul 27, 2020

Study contacts

Ying Jin, MD.,PhD
principal investigator · Sun Yat-sen University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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