Sintilimab Combined With Anlotinib and Taxane-Based Chemotherap for Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT07581821 | Recruiting Phase 2 DMC

• 1 other identifier: ZDWY.BYAFZZX.60
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Recurrent or Metastatic Nasopharyngeal Carcinoma

Keywords

Nasopharyngeal Carcinoma; Metastatic; Sintilimab; Anlotinib; taxane-based chemotherapy

Outcome Measures

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

  Through study completion, an average of 2 years

Secondary Outcomes (4)

• Disease control rate (DCR)

  Through study completion, an average of 2 years

• Duration of Response (DOR)

  Through study completion, an average of 2 years

• Progression-Free Survival (PFS)

  Through study completion, an average of 2 years

• Overall survival (OS)

  Through study completion, an average of 2 years

Study Arms (1)

Triple combination regimen

EXPERIMENTAL

Drug: 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.

Drug: Sintilimab + Anlotinib + taxane-based chemotherapy

Interventions

Sintilimab + Anlotinib + taxane-based chemotherapy DRUG

Drug: 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.

Triple combination regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 second-line standard regimens.
• At least one measurable lesion according to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1) is considered measurable if a lesion in a previously irradiated field is confirmed to have progressed;
• 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 central nervous system symptoms or no symptom exacerbation within at least two weeks; 3) No need for glucocorticoid therapy, discontinued glucocorticoid treatment within seven days prior to initial administration, or stabilized glucocorticoid dosage within seven days prior to initial administration reduced to below 10 mg/day prednisone (or equivalent dose)
• 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 toxicity associated with radiotherapy is restored to less than or equal to grade 1 (CTCAE 5.0, except for hair loss)
• ECOG score 0-1.
• Life expectancy\> 3 months.
• If there is a risk of pregnancy, all subjects (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 (or 180 days after the last study drug administration).

You may not qualify if:

• 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
• 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 administration;
• 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 enrollment)
• 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 those meeting the following criteria: 1) HBV viral loa
• Active HCV-infected subjects (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, intranasal administration of live attenuated influenza vaccine is not permitted.

Sponsors & Collaborators

• Ming-Yuan Chen: lead

Study Sites (1)

Fifth Affiliated Hospital of Sun Yat-sen University Zhuhai, Guangdong, China, 519000

Zhuhai, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Nasopharyngeal Carcinoma; Neoplasm Metastasis

Interventions

sintilimab; anlotinib

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Neoplastic Processes

Central Study Contacts

Ming-Yuan Chen, MD, PhD

CONTACT

+86-13903052650; chmingy@mail.sysu.edu.cn

Jijin Yao, MD

CONTACT

+86-15692424219; yaojj23@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Archiater

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: September 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 12, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)