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Trial · NCT07879599

Neoadjuvant Chemoradiotherapy Plus PD-1 Blockade ± CTLA-4 Blockade for Low/Intermediate-Risk Locally Advanced Rectal Cancer (pMMR/MSS): A National Multicenter, Prospective, Randomized Controlled Trial

NCT07879599, Phase 2, Phase 3, Not yet recruiting, Yao Hongwei

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Neoadjuvant Chemoradiotherapy Plus PD-1 Blockade ± CTLA-4 Blockade for Low/Intermediate-Risk Locally Advanced Rectal Cancer (pMMR/MSS): A National Multicenter, Prospective, Randomized Controlled Trial. Trials, record NCT07879599. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07879599

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Trial

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

Title
Neoadjuvant Chemoradiotherapy Plus PD-1 Blockade ± CTLA-4 Blockade for Low/Intermediate-Risk Locally Advanced Rectal Cancer (pMMR/MSS): A National Multicenter, Prospective, Randomized Controlled Trial
NCT number
NCT07879599
Status
Not yet recruiting
Phases
Phase 2, Phase 3
Enrollment
120 participants, estimated
Lead sponsor
Yao Hongwei
Conditions
Locally Advanced Rectal Cancer (LARC)
Interventions
Ipilimumab & Sintilimab, Sintilimab
First posted
2026-10-19
Last updated
2026-10-19

Source ClinicalTrials.gov

Registered outcomes1

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

ListOutcomeTime frameDescription
PrimaryComplete remission rateFrom enrollment to the end of treatment at 13 weeks
The complete response rate (CR) is defined as follows: Participants who undergo total mesorectal excision (TME) or local excision must achieve a pathological complete response (pCR; ypT0N0). Participants who do not undergo surgery and enter a watch-and-wait (W\&W) program must achieve a clinical complete response (cCR), as determined by a comprehensive assessment including digital rectal examination (DRE), endoscopy, pelvic magnetic resonance imaging (MRI), and tumor markers. The cCR must be confirmed by at least one repeat assessment performed 6-8 weeks later. If a participant is initially assessed as having a cCR but subsequently undergoes surgery, the final pathological findings will determine the response status. The same CR criteria will be applied to both study groups.

Outcomes0

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

None in this release.

Results by group0

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

None in this release.

Participant flow0

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

None in this release.

Adverse events0

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

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

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.

None in this release.

Trial comparisons0

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

None in this release.

Tests0

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

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07879599

GET https://conductscience.org/api/trials/v1/NCT07879599/registered