Comparing the Efficacy and Safety of Different Postoperative Adjuvant Regimens in Patients With Resectable Adenocarcinoma of the Esophagogastric Junction Who Underwent Radical Surgery After Neoadjuvant Chemotherapy Combined With Immunotherapy and Achieved pCR in Postoperative Pathology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study is to evaluate the efficacy and safety of different postoperative adjuvant regimens in patients with resectable adenocarcinoma of the esophagogastric junction who underwent radical surgery after neoadjuvant chemotherapy combined with immunotherapy and achieved pCR in postoperative pathology

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Neoadjuvant Chemoimmunotherapy Followed by Surgery and Postoperative Radioimmunotherapy

NCT06602843

Esophageal Squamous Cell Carcinoma

RECRUITING NA

Neoadjuvant Immunotherapy and Chemoradiotherapy for Locally Advanced Esophagogastric Junction Adenocarcinoma

NCT05505461

Adenocarcinoma of Esophagogastric Junction

NOT_YET_RECRUITING PHASE2

Pucotenlimab Combined With Chemotherapy as Perioperative Treatment for Locally Advanced Gastroesophageal Junction Carcinoma

NCT07092449

Gastroesophageal Junction Gastric / Gastroesophageal Junction Adenocarcinoma Neoadjuvant Chemoimmunotherapy +1 more

NOT_YET_RECRUITING NA

Neoadjuvant Immunotherapy Plus CRT Versus Neoadjuvant CRT for Locally Advanced Resectable ESCC

NCT04973306

Esophageal Squamous Cell Carcinoma Stage II Esophageal Squamous Cell Carcinoma Stage III

RECRUITING PHASE2/PHASE3

Evaluation for the Individualization of Therapy in Adenocarcinomas of the Gastroesophageal Junction

NCT02287129

Adenocarcinoma of the Esophagogastric Junction

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastric / Gastroesophageal Junction Adenocarcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SOX or XELOX with immunotherapy

Group Type EXPERIMENTAL

SOX plus PD-1 inhibitor

Intervention Type DRUG

SOX or XELOX plus PD-1 inhibitor

Immunotherapy

Group Type EXPERIMENTAL

PD-1 / PD-L1 monoclonal antibody

Intervention Type DRUG

PD-1/PD-L1 monoclonal antibody

SOX or XELOX

Group Type ACTIVE_COMPARATOR

SOX Chemotherapy

Intervention Type DRUG

SOX or XELOX

Tegafur-Ugotex or Capecitabine

Group Type ACTIVE_COMPARATOR

Tegafur-Ugotex or Capecitabine

Intervention Type DRUG

Tegafur-Ugotex or Capecitabine

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SOX plus PD-1 inhibitor

SOX or XELOX plus PD-1 inhibitor

Intervention Type DRUG

PD-1 / PD-L1 monoclonal antibody

PD-1/PD-L1 monoclonal antibody

Intervention Type DRUG

SOX Chemotherapy

SOX or XELOX

Intervention Type DRUG

Tegafur-Ugotex or Capecitabine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥ 18 years old, gender not restricted;
2. Subjects diagnosed with gastric cancer (GC) or gastroesophageal junction cancer (GEJC) through imaging and other examinations, and with histopathological diagnosis of adenocarcinoma;
3. HER2 overexpression or amplification results are negative;
4. Subjects who have received neoadjuvant chemotherapy for GC/GEJC before, and have undergone at least 3-4 cycles;
5. Having undergone radical surgical treatment and with postoperative pathological result reaching pCR
6. After radical surgery treatment, the investigator assesses that further adjuvant treatment is necessary, and the adjuvant treatment plan must be the one specified in this protocol.

Exclusion Criteria

* 1\) Gastric cancer that is known to be squamous cell carcinoma, undifferentiated carcinoma, or of other tissue types, or gastric cancer that is adenocarcinoma mixed with other tissue types; 2) Within 3 months before adjuvant therapy, there was a significant clinically significant bleeding symptom or a clear bleeding tendency; 3) Within 6 months before adjuvant therapy, had suffered from intestinal obstruction and/or had clinical signs or symptoms of digestive tract obstruction, including incomplete obstruction related to the original disease or requiring routine parenteral hydration, parenteral nutrition, or tube feeding; 4) Within 5 years before starting adjuvant therapy, was diagnosed with a malignant tumor (excluding malignant tumors with low metastasis and mortality risks, such as: skin basal cell carcinoma or cervical carcinoma in situ that has been adequately treated); 5) Within 30 days before starting adjuvant therapy, had participated in other clinical studies and used study drugs containing active ingredients;

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No