Trial · NCT06956716
Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma
NCT06956716, Phase 1, Phase 2, Recruiting, Zhejiang University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma. Trials, record NCT06956716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06956716
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Personalized Tumor Neoantigen mRNA Therapy for Advanced Intrahepatic Cholangiocarcinoma
- NCT number
- NCT06956716
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- Zhejiang University
- Conditions
- Advanced Intrahepatic Cholangiocarcinoma
- Interventions
- individualized anti-tumor new antigen iNeo-Vac-R01 injection, Gemcitabine + cisplatin (GP), Sintilimab injection
- First posted
- 2025-05-04
- Last updated
- 2025-05-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerable dose | 21±3 days after the last dose | According to the Commonly Used Adverse Events Criteria (CTCAE Version 5.0), the number of subjects with adverse events and/or dose-limiting toxicity was counted as an indicator of the safety and tolerable dose of iNeo-Vac-R01 injection. The evaluation period was the dosing observation period and the safety follow-up period. |
| Secondary | Objective reponse rate (ORR) | Up to 2 years | The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during the whole study |
| Secondary | Disease control rate (DCR) | Up to 2 years | The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during the whole study. |
| Secondary | Progression-free survival （PFS） | Up to 2 years | The time from enrolled to disease pregression or death from any cause during the whole study. |
| Secondary | Overall survival (OS) | Up to 2 years | The time from enrolled to death from any cause during the whole study. |
| Secondary | Overall Survival Rate (1-Y-OS%,2-Y-OS%,3-Y-OS%) | Up to 3 years | The percentage of patients surviving at 12, 24, and 36 months. |
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/NCT06956716
GET https://conductscience.org/api/trials/v1/NCT06956716/registered