Trial · NCT07183865
Hypofractionated Radiotherapy Combined With NALIRIF, PD-1 Antibody in Locally Recurrent Rectal Cancer(NOVELTY-R)
NCT07183865, Phase 2, Recruiting, Fudan University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Hypofractionated Radiotherapy Combined With NALIRIF, PD-1 Antibody in Locally Recurrent Rectal Cancer(NOVELTY-R). Trials, record NCT07183865. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07183865
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hypofractionated Radiotherapy Combined With NALIRIF, PD-1 Antibody in Locally Recurrent Rectal Cancer(NOVELTY-R)
- NCT number
- NCT07183865
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 44 participants, estimated
- Lead sponsor
- Fudan University
- Conditions
- Locally Recurrent Rectal Cancer
- Interventions
- radiotherapy, Irinotecan Hydrochloride Liposome, 5-FU, Leucovorin, SG001, C225, Bevacizumab
- First posted
- 2025-09-19
- Last updated
- 2025-09-19
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Local objective response rate | up to 1 year | the proportion of patients with the best pelvic response of confirmed complete or partial response according to RECIST 1.1, as assessed by the investigator. |
| Secondary | Extrapelvic objective response rate | up to 1 year | proportion of patients with confirmed extrapelvic complete or partial response per RECIST 1.1. |
| Secondary | Complete response rate | up to 1 year | proportion of patients with confirmed complete response per RECIST 1.1. |
| Secondary | R0 resection rate | up to 1 year | the proportion of patients who achieve R0 resection of pelvic recurrent tumour after therapy. |
| Secondary | Duration of response (DOR) | up to 3 year | time from the first documented pelvic objective response to pelvic or extrapelvic disease progression in patients with confirmed response. |
| Secondary | Progression-Free Survival(PFS) | up to 3 year | time from the date of start treatment until disease progression or censored at last follow-up or death. |
| Secondary | Overall Survival | up to 3 year | from the date of start treatment until the date of death from any cause or censored at last follow-up. |
| Secondary | Safety and tolerability of the treatment | up to 1 year | proportion of patients with treatment-related acute toxicities as assessed by NCI CTCAE v5.0, from treatment initiation until 90 days upon completion of immunotherapy. |
Source ClinicalTrials.gov
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.
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/NCT07183865
GET https://conductscience.org/api/trials/v1/NCT07183865/registered