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Trial · NCT06911684

Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR/MSS LARC.

NCT06911684, Phase 2, Recruiting, Sun Yat-sen University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR/MSS LARC. Trials, record NCT06911684. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06911684

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Trial

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

Title
Radiotherapy Plus Iparomlimab and Tuvonralimab (QL1706), Regorafenib, and CAPOX as Neoadjuvant Therapy for pMMR/MSS LARC.
NCT number
NCT06911684
Status
Recruiting
Phases
Phase 2
Enrollment
88 participants, estimated
Lead sponsor
Sun Yat-sen University
Conditions
Rectal Cancer Patients
Interventions
lparomlimab and Tuvonralimab Injection and regorafenib and CPAOX and short-course radiotherapy, lparomlimab and Tuvonralimab Injection and regorafenib and CPAOX and short-course radiotherapy
First posted
2025-04-04
Last updated
2026-04-28

Source ClinicalTrials.gov

Registered outcomes9

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

ListOutcomeTime frameDescription
PrimaryComplete response (CR)PeriproceduralComplete response: Pathological complete response and clinical complete response
SecondaryObjective response rate (ORR)3-4 weeks after completion of neoadjuvant therapyThe proportion of patients achieving a complete response (CR) or partial response (PR), evaluated according to RECIST v1.1.
SecondaryMajor Pathological Response (MPR)During the period after the primary lesion surgeryThe proportion of patients whose primary tumor shows ≤10% residual tumor cells on pathology.
SecondaryTumor Regression Grade (TRG)During the period after the primary lesion surgeryAssessed based on the 8th edition of the AJCC staging system to grade the extent of tumor regression
SecondaryR0 Resection RateDuring the period after the primary lesion surgeryThe proportion of surgical patients who achieve an R0 resection. R0 resection: All gross disease has been removed, and microscopic examination reveals all surgical margins free of tumor.
SecondaryOrgan Preservation Rate (OPR)1year after neoadjuvant therapy
The 1-year organ preservation rate is the percentage of patients attaining a complete clinical response (cCR) or near-complete clinical response (near-cCR) following neoadjuvant therapy, who then proceeded with non-surgical management or local excision, was monitored under a Watch \& Wait strategy or for 1 year post-local resection without undergoing radical surgery.
SecondaryEvent-free survival (EFS)2 years
EFS is defined as the time from randomization to the earliest occurrence of any of the following events: Tumor progression by imaging according to RECIST 1.1, Tumor recurrence (local or distant), confirmed by imaging or biopsy, for patients with no residual tumor after surgery, Death from any cause. Note: A second primary malignancy is not considered an EFS event.
SecondaryOverall survival (OS)5 yearsThe time interval between the date of randomization to the date of death. If the patient has been alive, the time until the last follow-up is taken as the overall survival period.
SecondaryIncidence of adverse eventsup to 30 days after last treatment
Assessed by Common Terminology Criteria for Adverse Events version 4.0. The overall adverse event rates and the immune-related adverse event rates will be compared between treatment arms using Chi-square test or Fisher's exact test, as appropriate.

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/NCT06911684

GET https://conductscience.org/api/trials/v1/NCT06911684/registered