Trial Title:
Fruquintinib as First Line Treatment in Patients With Recurrent Esophageal Squamous Cell Carcinoma
NCT ID:
NCT06010212
Condition:
Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Albumin-Bound Paclitaxel
Nedaplatin
Conditions: Keywords:
Fruquintinib ，Carrelizumab，Advanced ESCC
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Fruquintinib,Camrelizumab, Paclitaxel liposome combined with nedaplatin
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin
Description:
Phase Ib: Patients with advanced ESCC will be enrolled in a 3+3 dose escalation fashion,
with projected enrolment of between 9-18 patients to determine RP2D. Once the RP2D is
confirmed, the study will proceed to phase II.
fruquintinib: 3 mg, 4 mg, or 5 mg qd p.o., 2 weeks and 1 week, every 3 weeks ( dose
exploration phases were performed sequentially from the 4 mg group, refer to the study
design section for specific protocols); Camrelizumab: 200 mg I.V D1, every 3 weeks for
treatment cycles; Paclitaxel liposomes: 135 mg/m2 i.v d1, administered every 3 weeks, up
to 6 cycles; Nidaplatin: 70 mg/m2 i.v d1, administered every 3 weeks, up to 6 cycles.
Chemotherapy is used for up to 6 cycles, followed by maintenance therapy with
fruquintinib + Camrelizumab until disease progression or intolerable toxicity.
Phase II: Up to a total of 30 patients with advanced ESCC will be enrolled.
Arm group label:
Treatment group
Other name:
Fruquintinib, Camrelizumab, Paclitaxel liposome combined with nedaplatin
Summary:
This Study is a Single-center, Single-arm, Phase II Clinical Study. The Primary Objective
is to Evaluate the Efficacy and Safety of Fruquintinib, Carrelizumab, Paclitaxel
Liposomes combined with Nidaplatin as First-line Treatment in Advanced Esophageal
squamous cell carcinoma .
Detailed description:
Not provided
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily to join the study and sign the informed consent form;
2. Male or female patients aged 18-70 years (inclusive);
3. Histological or cytology-confirmed unresectable advanced or metastatic ESCC;
4. Identify at least one measurable lesion that meets the requirements of Efficacy
Evaluation Criteria for Solid Tumors (RECIST) version 1.1; If a lesion that has
previously received local therapy (radiotherapy, ablation, vascular intervention,
etc.) is the only lesion, there must be a clear radiographic basis for disease
progression of that lesion;
5. Previous systemic therapy for advanced ESCC;
6. ECOG ≤2;
7. Laboratory tests: neutrophil ≥ 1.5×109/L; platelets≥ 75×109/L; Hemoglobin≥ 90g/L;
Serum creatinine ≤ 1.5 times the upper limit of normal and creatinine clearance ≥ 60
ml/min; Urine protein <2+; If the urine protein ≥ 2+, the 24-hour urine protein
should be < 1 g; Alanine aminotransferase and glutamate aminotransferase ≤ 1.5 times
the upper limit of normal, or 3 times the upper limit of normal in the presence of
liver metastases≤; total bilirubin ≤ 1.5 times the upper limit of normal or 3 times
the upper limit of normal in the presence of liver metastases≤; albumin≥ 3.0 g/dL;
Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤
1.5x ULN;
8. Female patients with negative urine or blood hCG (except menopause and
hysterectomy), female patients of childbearing age and their partners take effective
contraceptive measures during the trial and within 3 months after the end of the
last dose (e.g., combination of hormones (including estrogen and progesterone)
combined with ovulation suppression, progestogen contraception combined with
ovulation suppression, intrauterine device, intrauterine hormone release system,
bilateral tubal ligation, vasectomy, avoidance of sexual behavior, etc.)
Exclusion Criteria:
1. Known to be allergic to recombinant humanized PD-1 monoclonal antibody drugs and
their components, or known to be allergic to fruquintinib or paclitaxel liposomes or
nidaplatin components;
2. Have a second tumor within the past 5 years, except cured basal cell carcinoma of
the skin or squamous cell carcinoma of the skin or carcinoma in situ of any other
site;
3. Uncontrolled serious medical diseases that the investigator believes will affect the
patient's ability to receive treatment with the study protocol, such as serious
medical diseases, including severe heart disease, cerebrovascular disease,
uncontrolled diabetes, uncontrolled infection, etc.;
4. The patient currently has gastrointestinal diseases such as active gastric and
duodenal ulcer and ulcerative colitis, or active bleeding in unremoved tumors, or
other conditions that may cause gastrointestinal bleeding and perforation as
determined by the investigator; or those who have previously had gastrointestinal
perforation or gastrointestinal fistula, which has not recovered after surgical
treatment;
5. Patients with evidence of bleeding tendency or history (such as melena, hematemesis,
hemoptysis, bloody stools, etc.) within 2 months before the first dose;
6. During screening, it was found that the tumor invaded the structure of large
vessels, such as pulmonary artery, superior vena cava or inferior vena cava, etc.,
and the investigator judged that there was a greater risk of bleeding;
7. History of arterial thrombosis or deep vein thrombosis within 6 months before the
first dose; or a stroke event and/or transient ischaemic attack within 12 months;
Thrombosis due to implantable intravenous infusion pump or catheter-derived
thrombosis, or superficial vein thrombosis, except for those with stable thrombosis
after conventional anticoagulation therapy;
8. Receiving chemotherapy, targeting, immunotherapy, clinical trials, etc. of other
investigational drugs within 4 weeks before the administration of the first
treatment;
9. Patients previously diagnosed with coronary heart disease or ischemic
cerebrovascular disease;
10. Pregnant or lactating female patients;
11. Have any other disease, metabolic disorder, abnormal result of physical examination
or laboratory test and have reason to suspect that may contraindicate the use of the
test drug, or affect the reliability of the results of the study;
12. Undergone major surgery within 28 days before the first dose, or received
radiotherapy within 14 days before the first dose, or used radiation agents
(strontium, samarium, etc.) within 56 days before the first dose;
13. Judged by the investigator to be unsuitable to participate in this study.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Start date:
August 25, 2023
Completion date:
July 1, 2026
Lead sponsor:
Agency:
The First Affiliated Hospital with Nanjing Medical University
Agency class:
Other
Source:
The First Affiliated Hospital with Nanjing Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06010212
