NCT06349148 The Effects of Immunonutrition Therapy on Locally Advanced Cervical Cancer Patients
| NCT ID | NCT06349148 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SHUANG ZHENG JIA, PhD |
| Condition | Cervical Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-01-01 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this open-label randomized control trial is to study the effect of immunonutrition in locally advanced cervical cancer (LACC) with standard concurrent chemoradiotherapy. LACC patients undergoing radical synchronous chemoradiotherapy will be randomized into the experimental group receiving enteral immunonutrition therapy and the control group receiving standard enteral nutrition support.The main purpose it aims to answer are:1）Can immunonutrition therapy improve patients' dose-limiting toxicity(DLT) and DLT-free survival? 2）Can immunonutrition therapy improve patients' nutritional status and quality of life?
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years; * Pathological histological diagnosis confirmed as cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; * Confirmed as Locally Advanced Cervical Cancer (LACC) based on gynecological examination and imaging assessment; * Undergoing CCRT/RT treatment; * Patients are conscious, able to communicate without barriers, and able to answer questions. * diagnosed with malnutrition according to the GLIM criteria; Exclusion Criteria: * Patients who received neoadjuvant chemotherapy or immunotherapy before treatment; * Patients with concomitant other malignant tumors or a history of malignant tumors; * Patients with special pathological types of tumors such as cervical small cell carcinoma or neuroendocrine tumors; * Patients staged as Ⅳb according to the International Federation of Gynecology and Obstetrics(FIGO) 2018 staging system; * Patients with other severe chronic debilitating diseases, such as severe heart failure (New York Heart Association Class II-IV), severe liver damage (alanine aminotransferase ≥ 3 times the upper limit of normal), severe renal insufficiency (GFR \< 30 ml/min\*1.73 m²), etc.; * Eastern Cooperative Oncology Group(ECOG) performance status ≥ 2; * Presence of other contraindications to CCRT/RT.
Contact & Investigator
SHUANGZHENG JIA
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT06349148 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cervical Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06349148 currently recruiting?
Yes, NCT06349148 is actively recruiting participants. Contact the research team at jiashuangzheng@cicams.ac.cn for enrollment information.
Where is the NCT06349148 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06349148 clinical trial?
NCT06349148 is sponsored by SHUANG ZHENG JIA, PhD. The principal investigator is SHUANGZHENG JIA at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 50 participants.
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