Gastric AdenocarcinomaNCT07662005
Objective Sleep Characteristics and Neoadjuvant Immunotherapy Response in Gastric/GEJ Cancer
An observational study of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by West China Second University Hospital.
Trial summary
This prospective observational study will enroll 120 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who are scheduled to receive neoadjuvant immunotherapy followed by radical surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Sleep
- What is being tested?
- Not applicable- observational study
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 26 Jun 2026to 31 Dec 2028
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with histologically confirmed locally advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who are assessed as resectable by imaging or a multidisciplinary team and are scheduled to receive neoadjuvant immunotherapy followed by radical surgery. Eligible participants should have stage II-III disease without distant metastasis, an ECOG performance status of 0-1, and no prior systemic anticancer therapy for the current tumor at study baseline.
Who may be able to join
- Age greater than 18 years, regardless of sex.
- Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
- Locally advanced, resectable disease as assessed by imaging or a multidisciplinary team, based on the 8th edition of the AJCC staging system, typically cT3-4a, any N, or any T with N-positive disease, corresponding to stage II-III disease, without distant metastasis.
- Scheduled to receive neoadjuvant therapy followed by radical surgery.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
- No prior systemic anticancer therapy for the current tumor at study baseline.
- Willing to participate in the study and able to provide written informed consent.
Who cannot join
- Presence of distant metastasis, peritoneal metastasis, or disease considered no longer suitable for curative-intent treatment.
- Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic anticancer therapy for the current tumor.
- Severe cognitive impairment, acute psychiatric disorder, or any other condition that prevents the participant from completing study procedures.
- Current treatment with antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications, with any of the following occurring within 4 weeks before enrollment:
- Increase or decrease in the dose of the relevant medication by 25% or more from the previous maintenance dose;
- Initiation, discontinuation, or replacement of antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications;
Show all 9Show fewer
- Adjustment of treatment due to worsening anxiety, depression, insomnia, or other psychiatric or psychological symptoms;
- Any medication change or psychological condition judged by the investigator to potentially affect sleep monitoring results or study compliance.
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Objective Sleep Characteristics and Response to Neoadjuvant Immunotherapy in Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A Prospective Observational Study
This prospective observational study will enroll 120 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who are scheduled to receive neoadjuvant immunotherapy followed by radical surgery. Non-invasive objective sleep monitoring will be performed during the neoadjuvant treatment period to assess sleep characteristics, including sleep duration, sleep efficiency, device-estimated deep sleep proportion, nocturnal awakenings, sleep regularity, heart rate, and heart rate variability. The primary objective is to evaluate the association between objective sleep characteristics and major pathological response (MPR) after neoadjuvant immunotherapy. This study will not alter standard treatment decisions, surgical procedures, or perioperative management.
- Conditions
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Sleep, Pathological Response
- Being tested
- Not applicable- observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
Not applicable- observational study
| Study group | Role | What they receive |
|---|---|---|
| Poor Objective Sleep Characteristics Group | Participants whose objective sleep characteristics during neoadjuvant immunotherapy are below the predefined median threshold, based on device-estimated deep sleep proportion or a predefined objective sleep composite index. This group is classified as having poor objective sleep characteristics for observational analysis only. Receives: Other: Not applicable- observational study | |
| Favorable Objective Sleep Characteristics Group | Participants whose objective sleep characteristics during neoadjuvant immunotherapy are at or above the predefined median threshold, based on device-estimated deep sleep proportion or a predefined objective sleep composite index. This group is classified as having favorable objective sleep characteristics for observational analysis only. Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response (MPR)
The proportion of participants who achieve major pathological response after neoadjuvant immunotherapy. MPR is defined as residual viable tumor cells of 10% or less in the resected tumor specimen after radical surgery.
Measured: From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.
Secondary outcomes (5)
Pathological complete response (pCR)
The proportion of participants who achieve pathological complete response after neoadjuvant immunotherapy. pCR is defined as the absence of residual viable tumor cells in the resected primary tumor specimen and, if applicable, resected lymph nodes after radical surgery.
Measured: From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.
R0 Resection Rate
The proportion of participants who undergo radical surgery with microscopically margin-negative resection. R0 resection is defined as no residual tumor at the surgical resection margins based on postoperative pathological assessment.
Measured: From enrollment to postoperative pathological assessment after radical surgery, approximately 3 to 6 months.
Event-Free Survival (EFS)
EFS is defined as the time from enrollment to the first occurrence of any event, including disease progression that precludes radical surgery, local or distant recurrence, or death from any cause, whichever occurs first.
Measured: From enrollment to disease progression, recurrence, death, or last follow-up, assessed up to approximately 36 months.
Recurrence-Free Survival (RFS)
RFS is defined as the time from radical surgery to the first documented local or distant recurrence, or death from any cause, whichever occurs first. Participants without recurrence or death will be censored at the date of last follow-up.
Measured: From radical surgery to recurrence, death, or last follow-up, assessed up to approximately 36 months.
Overall Survival (OS)
OS is defined as the time from enrollment to death from any cause. Participants who are alive at the time of analysis will be censored at the date of last follow-up.
Measured: From enrollment to death or last follow-up, assessed up to approximately 30 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start26 Jun 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- West China Second University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting Liu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662005
- Sponsor's protocol ID
- GCNI-SLEEP
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Sleep Characteristics and Response to Neoadjuvant Immunotherapy in Locally Advanced Gastric/Gastroesophageal Junction Adenocarcinoma: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07662005
- Acronym / sponsor ID
- GCNI-SLEEP
- Conditions
- Gastric Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma, Sleep, Pathological Response
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- West China Second University HospitalUniversity, hospital or other
- Study start
- 26 Jun 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective observational study will enroll 120 patients with locally advanced gastric or gastroesophageal junction adenocarcinoma who are scheduled to receive neoadjuvant immunotherapy followed by radical surgery. Non-invasive objective sleep monitoring will be performed during the neoadjuvant treatment period to assess sleep characteristics, including sleep duration, sleep efficiency, device-estimated deep sleep proportion, nocturnal awakenings, sleep regularity, heart rate, and heart rate variability. The primary objective is to evaluate the association between objective sleep characteristics and major pathological response (MPR) after neoadjuvant immunotherapy. This study will not alter standard treatment decisions, surgical procedures, or perioperative management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Poor Objective Sleep Characteristics Group | – | Other: Not applicable- observational studyParticipants whose objective sleep characteristics during neoadjuvant immunotherapy are below the predefined median threshold, based on device-estimated deep sleep proportion or a predefined objective sleep composite index. This group is classified as having poor objective sleep characteristics for observational analysis only. |
| Favorable Objective Sleep Characteristics Group | – | Other: Not applicable- observational studyParticipants whose objective sleep characteristics during neoadjuvant immunotherapy are at or above the predefined median threshold, based on device-estimated deep sleep proportion or a predefined objective sleep composite index. This group is classified as having favorable objective sleep characteristics for observational analysis only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with histologically confirmed locally advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who are assessed as resectable by imaging or a multidisciplinary team and are scheduled to receive neoadjuvant immunotherapy followed by radical surgery. Eligible participants should have stage II-III disease without distant metastasis, an ECOG performance status of 0-1, and no prior systemic anticancer therapy for the current tumor at study baseline.
Key inclusion criteria (7 listed)
- Age greater than 18 years, regardless of sex.
- Histologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
- Locally advanced, resectable disease as assessed by imaging or a multidisciplinary team, based on the 8th edition of the AJCC staging system, typically cT3-4a, any N, or any T with N-positive disease, corresponding to stage II-III disease, without distant metastasis.
- Scheduled to receive neoadjuvant therapy followed by radical surgery.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1.
Key exclusion criteria (9 listed)
- Presence of distant metastasis, peritoneal metastasis, or disease considered no longer suitable for curative-intent treatment.
- Prior neoadjuvant chemotherapy, immunotherapy, radiotherapy, or other systemic anticancer therapy for the current tumor.
- Severe cognitive impairment, acute psychiatric disorder, or any other condition that prevents the participant from completing study procedures.
- Current treatment with antidepressants, anxiolytics, sedative-hypnotics, or other psychotropic medications, with any of the following occurring within 4 weeks before enrollment:
- Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational studyNot applicable- observational study | Other | Favorable Objective Sleep Characteristics Group, Poor Objective Sleep Characteristics Group |
Primary outcome
Major pathological response (MPR)
Time frame: From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.
The proportion of participants who achieve major pathological response after neoadjuvant immunotherapy. MPR is defined as residual viable tumor cells of 10% or less in the resected tumor specimen after radical surgery.
5 secondary outcomes
Pathological complete response (pCR)
Time frame: From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.
R0 Resection Rate
Time frame: From enrollment to postoperative pathological assessment after radical surgery, approximately 3 to 6 months.
Event-Free Survival (EFS)
Time frame: From enrollment to disease progression, recurrence, death, or last follow-up, assessed up to approximately 36 months.
Recurrence-Free Survival (RFS)
Time frame: From radical surgery to recurrence, death, or last follow-up, assessed up to approximately 36 months.
Overall Survival (OS)
Time frame: From enrollment to death or last follow-up, assessed up to approximately 30 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Gastric Adenocarcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
RecruitingPhase 2
Perioperative Chemotherapy With Low-Dose Radiotherapy and Tislelizumab for Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
Gastric or Gastroesophageal Junction Adenocarcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by West China Second University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qing Li, PhD/MD (+8618702848178, liqing@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathological response (MPR) (time frame: From enrollment to postoperative pathological assessment after completion of neoadjuvant immunotherapy and radical surgery, approximately 3 to 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.