Esophageal Squamous Cell CarcinomaPhase 1/2NCT06010212
Fruquintinib as First Line Treatment in Patients With Recurrent Esophageal Squamous Cell Carcinoma
A Phase 1/2 study testing Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 25 Aug 2023to 1 Jul 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily to join the study and sign the informed consent form;
- Male or female patients aged 18-70 years (inclusive);
- Histological or cytology-confirmed unresectable advanced or metastatic ESCC;
- 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;
- Previous systemic therapy for advanced ESCC;
- ECOG ≤2;
- 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;
- 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.)
Who cannot join
- 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;
- 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;
- 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.;
- 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;
- Patients with evidence of bleeding tendency or history (such as melena, hematemesis, hemoptysis, bloody stools, etc.) within 2 months before the first dose;
- 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;
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- 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;
- Receiving chemotherapy, targeting, immunotherapy, clinical trials, etc. of other investigational drugs within 4 weeks before the administration of the first treatment;
- Patients previously diagnosed with coronary heart disease or ischemic cerebrovascular disease;
- Pregnant or lactating female patients;
- 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;
- 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;
- Judged by the investigator to be unsuitable to participate in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin as First Line Treatment in Patients With Recurrent Esophageal Squamous Cell Carcinoma
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 .
Read the detailed description
Not provided
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin
- Keywords
- Fruquintinib ，Carrelizumab，Advanced ESCC
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and NedaplatinDrug
Also called Fruquintinib, Camrelizumab, Paclitaxel liposome combined with nedaplatin
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Fruquintinib,Camrelizumab, Paclitaxel liposome combined with nedaplatin Receives: Drug: Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR（Objective response rate）
Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions.
Measured: 1 year
Secondary outcomes (2)
DCR（Disease control rates）
Disease Control Rate (DCR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) or stable disease (SD) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, progressive disease (PD) is >20% increase in sum of diameters of target lesions, stable disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
Measured: 1 year
PFS（Progression-free survival）
PFS is defined as the proportion of patients without disease progression (PD or relapse from CR) or death due to any cause at 6 months. Disease progression will be assessed using RECIST (version 1.1). Per RECIST 1.1 criteria, CR = disappearance of all target lesions, Partial Response (PR) is =>30% decrease in sum of diameters of target lesions, Progressive Disease (PD) is >20% increase in sum of diameters of target lesions, Stable Disease (SD) is <30% decrease or <20% increase in sum of diameters of target lesions.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start25 Aug 2023 (estimated)
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Fruquintinib,Camrelizumab, Paclitaxel liposome combined with nedaplatin
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yanhong Gu, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010212
- Sponsor's protocol ID
- 2022-013-CH11 IIT-ESCC
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to publish papers in 2025.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin as First Line Treatment in Patients With Recurrent Esophageal Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT06010212
- Acronym / sponsor ID
- 2022-013-CH11 IIT-ESCC
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- Fruquintinib ，Carrelizumab，Advanced ESCC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 25 Aug 2023 (estimated)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 24 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fruquintinib,Camrelizumab, Paclitaxel liposome combined with nedaplatin
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and NedaplatinFruquintinib,Camrelizumab, Paclitaxel liposome combined with nedaplatin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily to join the study and sign the informed consent form;
- Male or female patients aged 18-70 years (inclusive);
- Histological or cytology-confirmed unresectable advanced or metastatic ESCC;
- 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;
- Previous systemic therapy for advanced ESCC;
Key exclusion criteria (13 listed)
- 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;
- 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;
- 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.;
- 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;
- Patients with evidence of bleeding tendency or history (such as melena, hematemesis, hemoptysis, bloody stools, etc.) within 2 months before the first dose;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and NedaplatinAlso: Fruquintinib, Camrelizumab, Paclitaxel liposome combined with nedaplatinPhase 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. | Drug | Treatment group |
Primary outcome
ORR（Objective response rate）
Time frame: 1 year
Objective Response Rate (ORR) is defined as the percentage of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions.
2 secondary outcomes
DCR（Disease control rates）
Time frame: 1 year
PFS（Progression-free survival）
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Individual participant dataSharing planned: No. Plan to publish papers in 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanhong Gu principal investigator
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fruquintinib Combined With Camrelizumab, Paclitaxel Liposome and Nedaplatin in people with Esophageal Squamous Cell Carcinoma, run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tianzhu Qiu (18013873919, tianzhu_qiu@n.jmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR（Objective response rate） (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.