Trial · NCT04649489
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | TTF | 24 months | Time-to-treatment failure (TTF) after randomization, defined as the time from randomization to the first documented treatment failure (i.e., local recurrence or progression, EHS, or death from any cause). Tumor response will be determined by the IRF according to RECIST v1.1 |
| Secondary | OS | 24 months | Overall survival (OS) after randomization, defined as the time from randomization to death from any cause |
| Secondary | OS rate | 24 months | OS rate at 12 months, 18 months and 24 months, defined as the proportion of patients who have not experienced death from any cause at 12, 18 and 24months after randomization, respectively |
| Secondary | TTF | 24 months | TTF after randomization as determined by the investigator according to RECIST v1.1 |
| Secondary | TTF | 24 months | TTF after randomization as determined by the IRF and the investigator according to HCC mRECIST |
| Secondary | Time to EHS | 24 months | Time to EHS after randomization, defined as the time from randomization to first appearance of EHS, as determined by the IRF and the investigator |
| Other | AE/ADR | 24 months | Nature, incidence, severity and seriousness of the adverse events/ADR. Adverse events are graded according to the NCI-CTCAE (Version 5.0) |
| Other | RFS | 24 months | Recurrence-free survival (RFS) after randomization (Arm A), defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by the IRF and the investigator, or death from any cause (whichever occurs first) |
| Other | TTR | 24 months | Time-to-Recurrence (TTR) after randomization (Arm A), defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC, as determined by the IRF and the investigator |
| Other | R0 rate | 24 months | R0 rate (Arm A), defined as the proportion of patients who accomplish the complete resection of tumor with pathologically confirmed negative margin |
| Other | pCR rate | 24 months | Pathological complete regression (pCR) rate (Arm A), defined as the proportion of patients with no evidence of vital residual tumor cells on the complete resected specimen. pCR status will be analyzed by local pathologists at each site |
| Other | ORR | 24 months | Objective response rate (ORR) during atezo/bev treatment in induction phase before randomization and in Arm B after randomization, defined as the proportion of patients with a complete response (CR) or partial response (PR), as determined by the IRF and the investigator according to RECIST v1.1 and HCC mRECIST |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04649489/registered