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New treatment option for Recurrent or Metastatic Nasopharyngeal Carcinoma
Official title Sintilimab Combined With Anlotinib and Taxane-Based Chemotherap for Recurrent/Metastatic Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT07581821
What this study is testing
What is Sintilimab + Anlotinib + taxane-based chemotherapy?
Sintilimab + Anlotinib + taxane-based chemotherapy is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent or metastatic nasopharyngeal carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, single-arm Phase 2 study to evaluate the efficacy and safety of sintilimab combined with anlotinib and taxane-based chemotherapy in patients with recurrent (not unable to locally curative treatment) or metastatic NPC who failed at least first-line platinum-containing standard regimen and/or anti PD-1/L1.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Sign a written informed consent before implementing any trial-related procedures.
- Age is 18 or older and 65 or younger.
- Nasopharyngeal nonkeratinizing carcinoma (differentiated or undifferentiated, i.e. WHO type II or III) with histological or cytological evidence.
- Recurrent or metastatic nasopharyngeal carcinoma that has failed previous treatment with first-line platinum-containing standard regimens and/or...
- At least one measurable lesion according to the evaluation criteria for the how well it works of solid tumors (RECIST v1.1) is considered measurable...
You likely can't join if
- Diagnosis of a malignancy other than nasopharyngeal carcinoma within 5 years prior to the first dose (excluding cured basal cell carcinoma of the...
- Participants are currently enrolled in an treatment clinical study treatment or have received another investigational drug or used an investigational...
- Within 2 weeks before the first administration, patients received systemic treatment with traditional Chinese medicine or immunomodulatory drugs...
- Active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, glucocorticoids, or immunosuppressants) that occurred within 2...
- Study participants were receiving systemic glucocorticoid therapy (not including nasal, inhaled or other topical glucocorticoids) or any other form...
- The presence of clinically uncontrolled pleural/abdominal effusion (no drainage is required or the subject does not show significant increase in...
See the full eligibility criteria
- Sign a written informed consent before implementing any trial-related procedures.
- Age is 18 or older and 65 or younger.
- Nasopharyngeal nonkeratinizing carcinoma (differentiated or undifferentiated, i.e. WHO type II or III) with histological or cytological evidence.
- Recurrent or metastatic nasopharyngeal carcinoma that has failed previous treatment with first-line platinum-containing standard regimens and/or second-line standard regimens.
- At least one measurable lesion according to the evaluation criteria for the how well it works of solid tumors (RECIST v1.1) is considered measurable if a lesion in a previously irradiated field is confirmed to have...
- Participants with asymptomatic brain metastases or stable symptoms after local treatment may be enrolled, provided they meet the following criteria: 1) Measurable lesions outside the central nervous system; 2) No...
- Allow the subject to receive palliative radiotherapy (including cranial radiotherapy for symptomatic brain metastases), provided that the radiotherapy is completed at least 1 week prior to enrollment and that the...
- ECOG score 0-1.
- Life expectancy\> 3 months.
- If there is a risk of pregnancy, all people (male or female) should use contraception with an annual failure rate of less than 1% throughout the treatment period and for 120 days after the last study drug administration...
- Diagnosis of a malignancy other than nasopharyngeal carcinoma within 5 years prior to the first dose (excluding cured basal cell carcinoma of the skin, squamous epithelial carcinoma of the skin, and/or cured carcinoma...
- Participants are currently enrolled in an treatment clinical study treatment or have received another investigational drug or used an investigational device within 4 weeks prior to the first dose
- Within 2 weeks before the first administration, patients received systemic treatment with traditional Chinese medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use to...
- Active autoimmune diseases requiring systemic therapy (e.g., disease-modifying agents, glucocorticoids, or immunosuppressants) that occurred within 2 years prior to the first treatment. Replacement therapy (e.g...
- Study participants were receiving systemic glucocorticoid therapy (not including nasal, inhaled or other topical glucocorticoids) or any other form of immunosuppressive therapy within 7 days prior to the first study...
- The presence of clinically uncontrolled pleural/abdominal effusion (no drainage is required or the subject does not show significant increase in fluid over 3 days of discontinuation of drainage is eligible for...
- Known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;
- Patients who are known to be allergic to the active ingredient or excipient of the study drug, sintilimab and anlotinib hydrochloride;
- Patients with multiple factors affecting oral medications (e.g., dysphagia, postgastrectomy, chronic diarrhea, intestinal obstruction, etc.);
- Cough, severe liver and kidney dysfunction;
- Not fully recovered from toxicity and/or complications caused by any intervention prior to starting treatment (i.e., ≤1 grade or baseline, excluding fatigue or hair loss)
- History of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);
- Untreated active hepatitis B (defined as HBsAg-positive with HBV DNA copy count exceeding the upper limit of normal values in the laboratory department of the research center); Note: Eligible participants also include...
- Active HCV-infected people (HCV antibody positive and HCV-RNA levels above the detection limit);
- Vaccinated with a live vaccine within 30 days prior to the first dose (Day 1 of Week 1); Note: Influenza vaccine injections for seasonal influenza are permitted within 30 days prior to the first dose; however...
- Pregnant or lactating women;
- Participants with any severe or uncontrolled systemic diseases, such as: 1) significant and symptomatically severe abnormalities in rhythm, conduction, or morphology observed on resting electrocardiogram (e.g., complete...
- History or evidence of disease, abnormal treatment or laboratory test values that may interfere with the results of the trial and prevent the subject from participating in the study, or other conditions that the...
The study team makes the final eligibility decision.
Where it's taking place
- Zhuhai, Guangdong, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhuhai, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.