Oxaliplatin-Based Adjuvant Therapy for Gastrointestinal Neuroendocrine Carcinoma**

NCT07891572 | Enrolling By Invitation

• 1 other identifier: K9807
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with pathologically-confirmed gastrointestinal neuroendocrine carcinoma will be enrolled, to explore the efficacy and safety of oxaliplatin-based doublet chemotherapy in the adjuvant treatment of gastrointestinal neuroendocrine carcinoma. For patients after radical resection, adjuvant chemotherapy is recommended. XELOX, SOX or FOLFOX regimens can be selected based on the patient's physical status. Single-agent chemotherapy alone is not recommended.

Conditions

Gastrointestinal Neuroendocrine Carcinoma; Adjuvant Treatment; Resection

Outcome Measures

Primary Outcomes (1)

• DFS

  Disease-Free Survival

  For post-operative patients, defined as the time from initiation of adjuvant therapy until the date of tumour recurrence, metastasis, or death from any cause, assessed up to 60 months.

Secondary Outcomes (1)

• OS

  Defined as the time from initiation of adjuvant therapy or first-line treatment until the date of patient's death from any cause, assessed up to 60 months.

Study Arms (1)

oxaliplatin-based doublet chemotherapy

For patients after radical resection, adjuvant chemotherapy is recommended. XELOX, SOX or FOLFOX regimens can be selected based on the patient's physical status

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with pathologically-confirmed gastrointestinal neuroendocrine carcinoma will be enrolled

You may qualify if:

• Histopathologically-confirmed diagnosis of gastrointestinal neuroendocrine carcinoma
• Patients with radical resection of tumour, unresectable locally-advanced disease or metastatic disease, regardless of tumour stage;
• No restriction on gender, aged between 18 and 75 years old;
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1. Hematological, hepatic and renal function parameters meet the criteria for chemotherapy administration;
• Expected survival time ≥ 3 months;
• Agree to undergo examinations, treatment and follow-up in accordance with this study protocol; agree to provide clinicopathological and follow-up data required for the study; and consent to the use of study-related data for subsequent research;
• Voluntarily participate in this clinical trial, understand the study procedures and be capable of signing the informed consent form.

You may not qualify if:

• Presence of another concurrent malignant tumour within 5 years prior to enrolment;
• Received any anti-tumour therapy within six months before enrolment;
• In the investigator's judgment, the patient has concomitant diseases (such as uncontrolled hypertension, severe diabetes, thyroid disorders, psychiatric diseases, etc.) or any other conditions that would seriously endanger patient safety or prevent completion of this study.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: October 23, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 1, 2036
• Last Updated: October 23, 2026

Record last verified: 2026-09

Locations

CN (1)