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.
| Field | Value | Source |
|---|---|---|
| Title | Sintilimab Combined With LCCRT Followed by Capeox Chemotherapy in pMMR/MSS/MSI-L Locally Advanced Rectal Cancer | ClinicalTrials.gov |
| NCT number | NCT07917468 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 500 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Innovent Biologics (Suzhou) Co. Ltd. | ClinicalTrials.gov |
| Conditions | Locally Advanced Rectal Cancer | ClinicalTrials.gov |
| Interventions | Oxaliplatin, Placebo, radiotherapy, Capecitabine, Radical resection of rectal cancer, Sintilimab | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | EFS | throutg 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 |
| Secondary | OS | throutg treatment completion an average of 5 years | OS is defined as the time from the date of randomization until the date of death from any cause. | ClinicalTrials.gov |
| Secondary | CCR | up to 5 years after enrollment | CCR defined as the proportion of participants achieving pathological complete response (pCR) or clinical complete response (cCR) | ClinicalTrials.gov |
| Secondary | R0 resection rate | up to 5 years after enrollment | R0 resection rate: Descriptive summary of R0 resection rate | ClinicalTrials.gov |
| Secondary | EFS3 | 3yaers | 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 |
| Secondary | TRG | up to 5 years after enrollment | Pathological assessment of tumor regression grading (TRG) after neoadjuvant therapy | ClinicalTrials.gov |
| Secondary | neoadjuvant therapy completion rate | up to 5 years after enrollment | Neoadjuvant therapy completion rate: Descriptive summary of Neoadjuvant therapy completion rate | ClinicalTrials.gov |
| Secondary | OPR | up 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.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
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)