Trial · NCT07182565
Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcinoma
NCT07182565, Phase 1, Phase 2, Recruiting, West China Hospital
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcinoma. Trials, record NCT07182565. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07182565
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hypofractionated Radiotherapy Plus Immunochemotherapy for Neoadjuvant Treatment of Gastroesophageal Junction Adenocarcinoma
- NCT number
- NCT07182565
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 84 participants, estimated
- Lead sponsor
- West China Hospital
- Conditions
- Gastroesophageal Junction Adenocarcinoma, Hypofractionated Radiotherapy
- Interventions
- hypofractionated radiotherapy, PD-1 inhibitor, TS-1
- First posted
- 2025-09-19
- Last updated
- 2026-01-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability in Phase Ib | within 3 months after the HFRT | Safety will be assessed based on clinical adverse events, vital signs, and abnormalities in laboratory tests during the study period. Adverse events (AEs) will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. All deaths occurring within 90 days after the first dose of treatment or within 30 days after the last dose will be listed along with the causes of death. Laboratory abnormalities will be categorized according to NCI-CTCAE version 5.0. Maximum Tolerated Dose (MTD): If ≥1/3 of patients in a given dose cohort experience radiotherapy-related dose-limiting toxicities (DLTs) within 90 days, that dose level will be considered intolerable. The dose level immediately below will then be defined as the maximum tolerated dose (MTD). At least six evaluable patients are required in the MTD cohort. |
| Primary | pCR rate in Phase II | approximately 2 weeks after the resection of primary lesion | pCR rate: The proportion of patients who achieve pathological complete response (pCR), defined as the absence of viable tumor cells on microscopic examination after neoadjuvant therapy. |
| Secondary | R0 resection rate | approximately 2 weeks after the resection of primary lesion | number of R0 surgery divide all participants |
| Secondary | Objective response rate | From Baseline up to the pre-surgical assessment (performed within 28 days after the last dose of conversion therapy) | Objective response rate (ORR) is defined as the proportion of subjects with a confirmed Complete Response (CR) or Partial Response (PR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. A response (CR or PR) requires confirmation by a repeat assessment performed no less than 4 weeks after the criteria for response are first met. |
| Secondary | DFS(disease free survival) rate | Up to 3 years | evaluate the DFS rate after the resection of primary lesion（only patients who acquire R0 resection） |
| Secondary | OS(overall survival) rate | Up to 3 years | evaluate the OS rate after the neoadjuvant therapy |
| Secondary | Adverse Events (AEs) | From the first dose through 90 days after the last dose | The incidence, severity, and relationship of adverse events will be assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0. |
| Secondary | Quality of Life (QoL) - EORTC QLQ-C30 | Assessments are performed at Baseline, on Day 1 of each subsequent treatment cycle (each cycle is 21 days), at the end-of-treatment visit, and at 1, 3, 6, and 12 months post-surgery during follow-up. | Quality of life will be evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). |
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/NCT07182565
GET https://conductscience.org/api/trials/v1/NCT07182565/registered