Trial · NCT07912957
Neoadjuvant SHR-A1811 ± Adebrelimab in GC/GEJ
NCT07912957, Phase 2, Not yet recruiting, Fudan University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Neoadjuvant SHR-A1811 ± Adebrelimab in GC/GEJ. Trials, record NCT07912957. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07912957
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant SHR-A1811 ± Adebrelimab in GC/GEJ
- NCT number
- NCT07912957
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 62 participants, estimated
- Lead sponsor
- Fudan University
- Conditions
- Gastric Adenocarcinoma, Gastroesophageal Junction (GEJ) Adenocarcinoma
- Interventions
- Trastuzumab Rezetecan (SHR-A1811), Trastuzumab Rezetecan (SHR-A1811) + Adebrelimab
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathological complete response (pCR) rate | Assessed at surgery (approximately 3-4 weeks after completion of Cycle 3; each cycle is 21 days, total approximately 12-13 weeks after treatment initiation) | Central pathological review; pCR defined as ypT0N0 (no residual viable tumor in primary tumor bed and sampled lymph nodes) per American Joint Committee on Cancer (AJCC) 9th edition |
| Secondary | Major pathological response (MPR) rate | Assessed at surgery (approximately 3-4 weeks after completion of Cycle 3; each cycle is 21 days, total approximately 12-13 weeks after treatment initiation) | Central pathology; MPR defined as ≤10% residual viable tumor cells in primary tumor bed |
| Secondary | R0 resection rate | Assessed at surgery (approximately 3-4 weeks after completion of Cycle 3; each cycle is 21 days, total approximately 12-13 weeks after treatment initiation) | R0 defined as microscopic margin-negative resection |
| Secondary | Objective response rate (ORR) | Assessed at baseline and after 3 neoadjuvant cycles (each cycle is 21 days, total approximately 9 weeks after treatment initiation) | Imaging (CT/MRI/PET-CT) per RECIST 1.1 |
| Secondary | Event-free survival (EFS) | From treatment initiation to progression, recurrence, or death, assessed up to 24 months | Time from first study drug administration to disease progression precluding surgery, recurrence, or death from any cause, whichever occurs first. |
| Secondary | Overall survival (OS) | From treatment initiation to death from any cause, assessed up to 24 months | The time from the date of first study drug administration (treatment initiation) to the date of death from any cause. Participants who are alive at the time of analysis will be censored at the date they were last known to be alive. |
| Secondary | Incidence of adverse events (AEs) | From first dose to 90 days after last dose (each cycle is 21 days, total approximately 132 days after treatment initiation) |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07912957
GET https://conductscience.org/api/trials/v1/NCT07912957/registered