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Sintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal Cancer

NCT07917468, Phase 3, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.

Trial 10

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

FieldValueSource
TitleSintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal CancerClinicalTrials.gov
NCT numberNCT07917468ClinicalTrials.gov
StatusNot yet recruitingClinicalTrials.gov
PhasesPhase 3ClinicalTrials.gov
Enrollment500 participants, estimatedClinicalTrials.gov
Lead sponsorInnovent Biologics (Suzhou) Co. Ltd.ClinicalTrials.gov
ConditionsLocally Advanced Rectal CancerClinicalTrials.gov
InterventionsOxaliplatin, Placebo, radiotherapy, Capecitabine, Radical resection of rectal cancer, SintilimabClinicalTrials.gov
First posted2026-11-04ClinicalTrials.gov
Last updated2026-11-04ClinicalTrials.gov

Registered outcomes 8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescriptionSource
PrimaryEFSthroutg treatment completion an average of 5 years
EFS refers to the time from randomization to the first occurrence of any of the following events: disease progression precluding surgical treatment, local or distant recurrence, death from any cause, etc.
ClinicalTrials.gov
SecondaryOSthroutg treatment completion an average of 5 yearsOS is defined as the time from the date of randomization until the date of death from any cause.ClinicalTrials.gov
SecondaryCCRup to 5 years after enrollmentCCR defined as the proportion of participants achieving pathological complete response (pCR) or clinical complete response (cCR)ClinicalTrials.gov
SecondaryR0 resection rateup to 5 years after enrollmentR0 resection rate: Descriptive summary of R0 resection rateClinicalTrials.gov
SecondaryEFS33yaers
EFS3 defined as the proportion of participants who remain free from any of the following events for 3 years after randomization: disease progression precluding surgery, local or distant recurrence, or death from any cause
ClinicalTrials.gov
SecondaryTRGup to 5 years after enrollmentPathological assessment of tumor regression grading (TRG) after neoadjuvant therapyClinicalTrials.gov
Secondaryneoadjuvant therapy completion rateup to 5 years after enrollmentNeoadjuvant therapy completion rate: Descriptive summary of Neoadjuvant therapy completion rateClinicalTrials.gov
SecondaryOPRup to 5 years after enrollment
The definition of organ preservation is: no radical total mesorectal excision (TME) performed, and no local regrowth, unless such regrowth can be salvaged by local excision achieving a limited, radical (R0) resection, with no permanent stoma (including a protective stoma that has never been reversed, or a stoma resulting from adverse events and/or poor functional outcome, or a permanent stoma).
ClinicalTrials.gov

Outcomes 0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured asSource

Results by group 0

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnitsSource

Participant flow 0

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits countedSource

Adverse events 0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEventsSource

Adverse event totals 0

The totals the trial posted for each group.

TotalGroupAffectedAt riskSource

Papers 0

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource

Grants 0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal yearsSource

Trial comparisons 0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource

Tests 0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource

Source 5

FieldValueSource
Releasetrials-2026-11-12-0.4.0ClinicalTrials.gov
Release manifest SHA-2560f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4ClinicalTrials.gov
Registry capture2026-11-12ClinicalTrials.gov
Results copy, AACT2026-03-23ClinicalTrials.gov
NIH clinical studies file2026-11-13ClinicalTrials.gov

The same record as JSON

Release trials-2026-11-12-0.4.0

ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)