An observational study in Esophageal Cancer, sponsored by Peking University Cancer Hospital & Institute. Status unknown at 23 sites in China. Open to participants aged Up to 80 Years. Per ClinicalTrials.gov, last updated 2018-01-23.
Sponsored by Peking University Cancer Hospital & Institute · Observational
Among 502 studies in Esophageal Neoplasms with a site in China — 210 open to participants now, 237 under way, 28 of them phase 3. Esophageal Neoplasms · China.
Among the 502 studies in Esophageal Neoplasms with a site in China, this one is the 41st largest by planned enrollment of the 108 observational ones that give a count, is one of 30 that started in 2017, is one of 108 observational ones, and was the 140th registered.
1,873 studies on the registry are indexed under Esophageal Neoplasms; 501 are open to participants now.
Browse Esophageal Neoplasms studies →210 of the 502 studies in Esophageal Neoplasms with a site in China are open now. Recruiting first, the newest first:
Ruijin Hospital · Sites in China
Sun Yat-sen University · Sites in China
Peking University First Hospital · Sites in China
Tianjin Medical University Cancer Institute and Hospital · Sites in China
Sanofi · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 387 Esophageal Neoplasms studies recruiting now, 245 (63%) set no upper age limit and 75 (19%) stop at 75 or younger; 19 take children under 18; 36 take healthy volunteers.
This study: Up to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
502 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 81 · Phase 2 189 · Phase 3 69 · Phase 4 8
First in 1995; this study’s year is marked. 30 started in 2017.
This study's planned enrollment of 600 is above the median of 200 across 432 observational studies indexed under Esophageal Neoplasms.
Median enrollment 80 across the 394 interventional studies, 300 across the 108 observational. Of the 121 that completed or were terminated, 7 (6%) have results posted.
This tab as a report to print or save as PDF → With an account.
81 of 502 have an industry lead sponsor. The 10 most frequent:
Peking University Cancer Hospital & Institute is the lead sponsor of 268 studies on the registry; 128 are open to participants now.
Peking University Cancer Hospital & Institute has 9 studies filed under Esophageal Neoplasms — fewer than ten, so there is no comparison to draw.
62 of the studies in Esophageal Neoplasms with a site in China that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04513808Phase 3The Cleveland ClinicTotal Intravenous Anesthesia and Recurrence Free Survival | 2026-12 |
| NCT04415853Phase 3Sunshine Lake Pharma Co., Ltd.Study of Larotinib in Unresectable Advanced or Recurrent Esophageal Cancer | 2027-08 |
| NCT07303231Phase 3Fujian Medical University Union HospitalThe Value of Indocyanine Green-guided Near-infrared Fluorescence Technology in Tracing Sentinel Lymph Nodes During Esophagectomy | 2027-08-01 |
| NCT05252078Jiangxi Provincial Cancer HospitalAnlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients | 2026-11 |
| NCT05094336AmgenA Study of Anvumetostat in Participants With Advanced MTAP-null Solid Tumors (MTAPESTRY 101) | 2026-11-30 |
Among the 502 studies in Esophageal Neoplasms with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This clinical trial is designed to be a multi-center prospective observational study which shall compare the effect of different postoperative home nutrition modes on recent nutritional index (weight/BMI) of patients with esophageal cancer and recent outcomes. Different postoperative home nutrition modes adopted in this study includes oral natural diet, oral nutrition supplement and tube feeding.
STUDY BACKGROUND Esophageal cancer is a common cancer in China and due to its influence on diet intake, patients with esophageal cancer are often combined with nutrition deficiency, which causes relatively high nutrition risk to treatment. Studies conducted by Martin et al showed that the degree of body weight loss in patients with malignancy is related to BMI level and prognosis. The patients with severe body weight loss and low BMI have poor prognosis, especially for patients with esophageal cancer.
At present, perioperative nutrition support for patients with esophageal cancer has been recognized and has been recommended as routine in 2017 NCCN guideline. How to implement good home nutrition within one month after patient discharge and recover nutrition index as soon as possible has become a focus for esophageal surgeon.
Many clinical trials have already investigated enteral nutrition support approach during anti-cancer treatment period in patients with malignancy. However, only a few clinical trials are good designed. Therefore the investigators hope to via this multi-center prospective observational study to provide evidence for this question.
OBJECTIVES:
OUTLINE:
Included patients shall be divided into three groups according to the treatment plan of all centers, including oral natural diet, oral nutrition supplement and tube feeding. As for patients in oral natural diet group, the patients shall receive oral natural diet. As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d. As for patients in tube feeding group, in addition to oral natural die, the participants shall receive tube feeding enteral supplement providing 750-1500kcal/d.
All the included patients shall be followed up weekly within 1-3 weeks after discharge via telephone, at Day 30 after discharge and at Day 90 after discharge to assess the effectiveness and safety of different home nutrition supplement approaches.
PROJECTED ACCRUAL: A total of 600 patients will be accrued for this study.
Patients with esophageal cancer who undergo surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
As for patients in oral natural diet group, the the participants shall receive oral natural diet.
As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d.
Dietary Supplement: Oral nutrition supplement
As for patients in tube feeding group, in addition to oral natural die, the participants shall receive tube feeding nutrition supplement providing 750-1500kcal/d.
Dietary Supplement: Tube feeding nutrition supplement
As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d.
As for patients in tube feeding group, in addition to oral natural die, the participants shall receive Tube feeding nutrition supplement providing 750-1500kcal/d.
Percentage of 5% body weight loss on Day 30
Percentage of 5% body weight loss on Day 30 compared to the body weight at discharge
Time frame: Day 30 after discharge
Completion ratio of different nutrition support approaches
Completion ratio of different nutrition support approaches
Time frame: Day 30 after discharge
Quality of life assessment using EORTC QLQ-C30 scale and QLQ-OG25 scale
Assessment on patients' quality of life using EORTC QLQ-C30 scale and QLQ-OG25 scale in different nutrition support approach groups and investigate the relationship between different nutrition support approaches and patients' quality of life
Time frame: Day30 and Day 90
Complications of home enteral nutrition support
Assessment on complications of home enteral nutrition support
Time frame: Day30
Delay and interruption ratio of adjuvant treatment
Delay and interruption ratio of adjuvant treatment including whether chemotherapy and radiotherapy can be implemented on time
Time frame: Day 30 and Day 90
Re-hospitalization ratio
Re-hospitalization ratio within 90 days after discharge
Time frame: Day 90
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2017 (actual). Primary completion is estimated for Sep 2018, 12 months after the start.
Of 152 non-industry observational studies under Esophageal Neoplasms, half reached primary completion within 81 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 252. This study's planned 12 months is below that.
Counting every sponsor, half of 174 studies reached it within 60 months; a quarter within 33 and three quarters within 252.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Peking University Cancer Hospital & Institute →