A phase II study of biweekly Docetaxel + Nedaplatin in advanced esophageal cancer in patients previously treated with FP and anti-PD-1 antibodies

JRCT ID: jRCTs061210089

Registered date:24/03/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer
• Date of first enrollment: 24/03/2022
• Target sample size: 18
• Study type: Interventional
• Intervention(s): docetaxel and nedaplatin are administered intravenously on day1 every 2 weeks at a dose of 30mg/m2 (body surface area), until disease progression or unmanageable toxicity

Outcome(s)

• Primary Outcome: Adverse events
• Secondary Outcome: Overall survival, progression free survival, response rate, Disease control rate.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients diagnosed with unresectable or recurrent esophageal cancer who are not eligible for curative treatment (surgery, radiotherapy, chemoradiotherapy)and have been previously treated with 5FU +CDDP and PD-1 blocking antibody
1) For unresectable esophageal cancer, all of the following i)-iii) are met.
i) Distant metastasis other than #102 mid (middle deep cervical lymph node)or #104 (supraclavicular lymph node).
Even if the short diameter of the lymph node is less than 10 mm, it is considered a lymph node metastasis if it can be clearly judged as a tumor lesion by FDG-PET, ultrasonography, or clinical course.
ii) Tumor depth is cT1-4a.
iii) Dysphagia score <- 2 (semi-solid or harder food intake is possible)and the patient can pass a conventional endoscope.
2) For recurrent esophageal cancer, both i) and ii) are met.
i) Distant metastasis other than #102 mid (middle deep cervical lymph node) or #104 (supraclavicular lymph node). (Only one distant metastasis in either #102 mid or #104 is eligible if it is a recurrence in the radiation field after radical (chemo)radiation therapy.)
Even if the short diameter of the lymph node is less than 10 mm, it is considered as lymph node metastasis if it can be clearly judged as tumor lesion by FDG-PET, ultrasonography, or clinical history.
ii) Dysphagia score <- 2 (semi-solid or more solid food intake is possible.)
Note) Cases in which recurrence is suspected based on elevated tumor markers or clinical symptoms alone are not applicable. If the patient has a history of multiple cancers other than esophageal cancer, confirm that it is a recurrence of esophageal cancer by clinical history or histological diagnosis.
2.The primary lesion is located in the cervical esophagus, thoracic esophagus, or esophagogastric junction (UICC-TNM 7th edition).
3.Histopathologically diagnosed as either squamous cell carcinoma or adenosquamous cell carcinoma*.
*Siewert type I (ineligible for Siewert type II/III (see 3.1.1.)).
4.At least one measurable lesion can be identified on imaging studies within 28 days prior to enrollment.
5.Patients within 28 days from disease progression
6.Performance status (ECOG): 0 to 1.
7.Over 20 years old at the time of enrollment.
8.Patients who are expected to survive for 3 months from the start date of treatment.
9.The following treatment-free periods must have occurred from the end of the previous treatment.
Radiation therapy:4weeks
Surgical therapy with organ resection:2weeks
Chemotherapy:2weeks
Immunotherapy:2weeks
Other investigational drugs:4weeks
10.Patients whose latest blood test results meet all of the following criteria (within 14days prior to enrollment)
6.Adequate organ function within 14days prior to enrollment
WBC:<=12,000/mm3
Neutrophil:>=1,500/mm3
Hb:>=9.0 g/dl
Plt:>=100,000/mm3
T-Bil:<=1.5mg / dl
Patients with obstructive jaundice who have undergone decongestive procedure, such as PTCD, are eligible if the procedure was performed within 14 days prior to enrollment and the most recent test within 14 days prior to enrollment confirms that the patient meets the above criteria (T. Bil <-2.0 mg/dl).
AST(GOT),ALT(GPT):within 2.5 times the normal upper limits
Ccr:<=1.2mg/dl
CCr:>=50ml / min (Cockcroft- Gault)
CCr should be greater than or equal to 50 mL/min/body as estimated by the Cockcroft-Gault equation. Even if the estimated value is less than 50 mL/min/body, the patient is eligible if the measured value is confirmed to be 50 mL/min/body or more.
11.No blood transfusion within 14 days prior to enrollment
12.Informed consent was obtained in writing from the patient.

Exclude criteria

1.Patients with a history of taxane use in the previous treatment history. (Preoperative or postoperative adjuvant therapy and radical chemoradiation can be enrolled if 180 days have passed since the last dose.)
2.Patients with Grade 2 or higher peripheral neuropathy at the time of obtaining written informed consent
3.Patients who have history of severe drug allergy.
4.Patients who have active infectious disease.
5.Patients with active multiple cancers (Active multiple cancers are defined as concurrent multiple cancers and heterogeneous multiple cancers with a disease-free interval of 5 years or less. However carcinoma in situ (intraepithelial carcinoma) or intramucosal carcinoma that are considered curable by local treatment are not included in active multiple cancers).
6.Patients have symptomatic bone or brain metastases.
7.Patients who has severe complication
Infectious disease on antibiotics.
diabetes mellitus under treatment or poorly controlled by continuous insulin use
poorly controlled hypertension
myocardial infarction occurring within 6 months
unstable angina pectoris
liver cirrhosis
Interstitial pneumonia or pulmonary fibrosis
8.Patients who want to be pregnant and /or pregnant woman
9.Patients with psychosis or psychiatric symptoms that make it difficult to participate in clinical research
10.Patients who was judged to be unsuitable for this clinical trial

Related Information

• Primary Sponsor: Nagano Hiroaki
• Secondary Sponsor: Takeda Shigeru