Sintilimab Combined With Anlotinib and Taxane-Based Chemotherap for Recurrent/Metastatic Nasopharyngeal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorMing-Yuan Chen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 in situ that has been resected);
Participants are currently enrolled in an interventional 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 control pleural effusion) for anti-tumor indications
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., thyroid hormone, insulin, or physiologically administered glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy
Trial design
Design model
Single group
Treatments tested in this trial
Sintilimab + Anlotinib + taxane-based chemotherapy
DrugDrug: Sintilimab 200mg, D1, Q3W, iv drip, Drug: Anlotinib 12mg, D1-14, Q3W, PO Drug: Taxane chemotherapy Docetaxel, 75mg/m², D1, Q3W, iv drip, maximum 6 cycles; or paclitaxel, 175mg/m², D1, Q3W, iv drip, maximum 6 cycles; or nab-paclitaxel, 260mg/m², D1, Q3W, iv drip, maximum 6 cycles. Select one chemotherapeutic drug not previously used.
Treatment groups
33 Participants
are divided into 1 treatment groupGroup A: Triple combination regimenExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Objective response rate (ORR)
Objective response rate (ORR) is defined as the proportion of patients with a complete response or partial response to treatment
Time frame
Through study completion, an average of 2 yearsSecondary outcomes
1
Disease control rate (DCR)
Disease Control Rate (DCR) is defined as the percentage of patients who have achieved complete response, partial response and stable disease to a therapeutic intervention in clinical trials of anticancer agents
Time frame
Through study completion, an average of 2 years2
Duration of Response (DOR)
Duration of Response (DOR) is defined as time from the first assessment of CR or PR until the date of the first occurrence of PD, or until the date of death
Time frame
Through study completion, an average of 2 years3
Progression-Free Survival (PFS)
Progression-Free Survival (PFS) is defined as the time from randomization to progression or death
Time frame
Through study completion, an average of 2 years4
Overall survival (OS)
Overall survival (OS) is defined as the duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ming-Yuan Chen
Lead sponsor
Sun Yat-sen University
Sponsor institution
Source ClinicalTrials.gov