Gastrointestinal Neuroendocrine CarcinomaNCT07891572
Oxaliplatin-Based Adjuvant Therapy for Gastrointestinal Neuroendocrine Carcinoma**
An observational study of Gastrointestinal Neuroendocrine Carcinoma and Adjuvant Treatment, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastrointestinal Neuroendocrine Carcinoma, Adjuvant Treatment, Resection
- How many people
- 42 participants
- Where
- 1 siteChina
- Study dates
- Sep 2026to Sep 2036
- Phase
- Observational
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pathologically-confirmed gastrointestinal neuroendocrine carcinoma will be enrolled
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: Efficacy and Safety of Oxaliplatin-Based Doublet Regimens as Adjuvant Therapy for Gastrointestinal Neuroendocrine Carcinoma
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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DFS
Disease-Free Survival
Measured: 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
Overall Survival
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2031 (estimated)
- Study completionSep 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Neuroendocrine CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, YueJuan Cheng, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891572
- Sponsor's protocol ID
- K9807
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No