A Phase 1/2 interventional study of Radiotherapy and Albumin-Bound Paclitaxel in Esophageal Cancer, Chemoradiotherapy and Albumin-bound Paxlitaxel, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Recruiting at 5 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 1/2, Interventional, and Treatment
This phase I/II clinical study is designed to evaluate the 1 year local tumor control rate of chemoradiotherapy using albumin-bound paclitaxel and cisplatin in unresectable esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.
This Phase I/II clinical study is meticulously designed to assess the one-year local tumor control rate of a chemoradiotherapy regimen that combines albumin-bound paclitaxel and cisplatin in patients with unresectable esophageal squamous cell carcinoma (ESCC). The selection of participants is guided by the Nutritional Risk Screening (NRS2002) tool, which ensures that nutritional risk factors are adequately considered and managed throughout the study.
The trial will enroll patients diagnosed with unresectable ESCC, a condition where surgical intervention is not feasible due to the tumor's location, size, or patient comorbidities. Participants will undergo a thorough nutritional assessment using the NRS2002 criteria, which evaluates factors such as weight loss, body mass index, dietary intake, and severity of disease to determine their nutritional risk score. This screening is crucial as it helps identify patients who may benefit from nutritional interventions, which could potentially improve their overall response to the treatment and quality of life.
Once enrolled, patients will receive a combination chemoradiotherapy of albumin-bound paclitaxel and cisplatin. Albumin-bound paclitaxel is chosen for its ability to improve the delivery and efficacy of paclitaxel, a chemotherapy drug, by enhancing its solubility and distribution within the body. Cisplatin, a platinum-based chemotherapy agent, is included due to its well-established efficacy in treating various cancers, including esophageal cancer. This combination aims to maximize tumor reduction while managing potential side effects.
The primary endpoint of the study is to determine the local tumor control rate at one year, which refers to the percentage of patients whose tumors have not progressed or recurred within the treated area during this period. Secondary endpoints include overall survival, progression-free survival, and assessment of treatment-related toxicity. Additionally, the study will monitor changes in patients' nutritional status and quality of life, aiming to provide comprehensive insights into the efficacy and safety of this chemoradiotherapy regimen.
Regular follow-ups and imaging studies, such as CT scans or PET scans, will be conducted to evaluate the tumor response and detect any signs of progression. Blood tests and other laboratory assessments will be performed periodically to monitor patients' overall health and manage any adverse effects promptly. The data collected from this study will contribute valuable information to the ongoing efforts to improve treatment outcomes for patients with unresectable esophageal squamous cell carcinoma.
1,631 studies on the registry are indexed under Esophageal Neoplasms; 469 are open to participants now.
This study's planned enrollment of 105 is above the median of 60 across 1,198 interventional studies indexed under Esophageal Neoplasms.
Browse Esophageal Neoplasms studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 387 studies on the registry; 275 are open to participants now.
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Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit
Exclusion Criteria:
Chemoradiotherapy arm receives intensity-modulated radiation therapy, volume modulated arc therapy or tomotherapy concurrently with albumin-bound paclitaxel and cisplatin (weekly intravenous infusion in 5-6 weeks).
Radiation: Radiotherapy · Drug: Albumin-Bound Paclitaxel · Drug: Cisplatin
59.92Gy and 2.14Gy in 28 fractions to PGTV and 50.4Gy and 1.8Gy in 28 fractions 5 days every week in 5.5 weeks.
100mg/d weekly,repeatedly on the first day,by intravenous infusion in 5-6 weeks.
Also known as: Nab-Paclitaxel
25mg/m2 weekly,by intravenous infusion in 5-6 weeks.
Also known as: platinum
Local control rate
Control rate of primary esophageal cancer and metastatic lymph nodes within irradiation fields
Time frame: 1 year from the start of treatment to tumor recurrence
Number of participants with acute toxicities
Acute toxicities are evaluated by NCI-CTC version 5.0
Time frame: 10 week, from the start of treatment to 1 month after chemoradiotherapy
Objective response rate
Objective Response Rate are evaluated by RECIST 1.1
Time frame: 5.5 week
Disease Free Survival
The time from treatment to progression or death
Time frame: 1 year, 2 year
Progression Free Survival
The time from treatment to progression or death
Time frame: 1 year, 2 year
Overall Survival
The time from treatment to death from any cause
Time frame: 1 year, 2 year
Radiomics analysis
Radiomics analysis for tumor response and survival prediction with pre- and post-chemoradiotherapy based on MRI and CT simulation
Time frame: 5.5 week
ctDNA analysis
ctDNA analysis to monitor therapeutic efficacy including tumor response and survival outcome
Time frame: 4 week, 2 month, 1 year, 2 year
Started Oct 2019 (actual). Primary completion is estimated for Dec 2025, 74 months after the start.
Of 63 phase 1/2 interventional studies under Esophageal Neoplasms, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 116. This study's planned 74 months is above that.
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Studies of the drugs tested here: Albumin-Bound Paclitaxel · Cisplatin
Cancer Institute and Hospital, Chinese Academy of Medical Sciences →