Gemcitabine + Docetaxel + Toripalimab for Nasopharyngeal Cancer

Recruiting in Palo Alto (17 mi)

Overseen by A Dimitrios Colevas, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Stanford University

Must not be taking: Anticancer treatments

Disqualifiers: Autoimmune disease, Organ transplant, AIDS, others

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of the research is to test the safety and efficacy of the investigational drug in human subjects with cancer.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot use any other anti-cancer treatments while participating.

What data supports the effectiveness of the drug Toripalimab in treating nasopharyngeal cancer?

In a study, adding toripalimab to standard chemotherapy for advanced nasopharyngeal cancer significantly improved the time patients lived without the disease getting worse, compared to chemotherapy alone. Patients receiving toripalimab had a median progression-free survival of 11.7 months versus 8.0 months for those on placebo, showing a 40% reduction in the risk of death. ^{1 2 3 4 5}

Is the combination of Gemcitabine, Docetaxel, and Toripalimab safe for treating nasopharyngeal cancer?

In a study with nasopharyngeal cancer patients, adding Toripalimab to chemotherapy showed a manageable safety profile, though there were more immune-related side effects and infusion reactions compared to chemotherapy alone. Serious side effects were similar between those who received Toripalimab and those who did not. ^{2 5 6 7 8}

How is the drug Toripalimab different from other treatments for nasopharyngeal cancer?

Toripalimab is unique because it is a monoclonal antibody that targets PD-1, a protein on immune cells, helping the immune system attack cancer cells more effectively. When combined with chemotherapy drugs like gemcitabine and docetaxel, it has shown to improve progression-free survival in patients with recurrent or metastatic nasopharyngeal cancer compared to chemotherapy alone. ^{2 3 9 10 11}

Research Team

A Dimitrios Colevas, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for individuals with nasopharyngeal carcinoma associated with the Epstein-Barr Virus. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and have a confirmed diagnosis of the condition being studied.

Inclusion Criteria

Life expectancy: 3 months at least

I am at least 18 years old.

CBC/differential obtained within 21 days prior to day 1 of treatment, with adequate bone marrow function defined as follows:

Exclusion Criteria

I am not currently using any cancer treatments.

I have not had a heart attack in the last 6 months.

I have received systemic anticancer treatment for nasopharyngeal cancer.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive three q 21-day cycles of gemcitabine, docetaxel, and toripalimab

12 weeks

Radiation

Participants receive radiation to 70 Gy plus concurrent weekly cisplatin

8 weeks

Adjuvant Therapy

Participants receive adjuvant capecitabine and toripalimab

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• Toripalimab (Monoclonal Antibodies)

Trial Overview The study tests Toripalimab's safety and effectiveness in treating EBV-associated nasopharyngeal cancer, alongside standard treatments like concurrent chemoradiation followed by adjuvant therapy.

Participant Groups

Group I: Gemcitabine, Docetaxel and Capecitabine Experimental Treatment 2 Interventions

Patients will receive three q 21-day cycles of gemcitabine 1000 mg/m2 plus docetaxel 75 mg/m2 plus toripalimab 240 mg, followed by radiation to 70 Gy plus concurrent weekly cisplatin, 40 mg/m2 up to 7 doses, followed by adjuvant capecitabine 650 mg/m2 BID for one year plus toripalimab 240 mg q 21 days for 9 doses.

Toripalimab is already approved in China for the following indications:

Approved in China as Loqtorzi for:

• Nasopharyngeal carcinoma
• Esophageal cancer
• Small cell lung cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Stanford University Palo Alto, CA

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2527

Patients Recruited

17,430,000+

Findings from Research

The triple combination therapy of gemcitabine, apatinib, and toripalimab (GAT) showed a high objective response rate of 90.2% in 41 patients with recurrent/metastatic nasopharyngeal carcinoma, indicating strong antitumor activity.

While GAT therapy was effective, it also resulted in significant adverse events, with 56.1% of patients experiencing grade 3 or 4 side effects, including a notable risk of nasopharyngeal necrosis, particularly in patients with a history of repeated radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gemcitabine combined with apatinib and toripalimab in recurrent or metastatic nasopharyngeal carcinoma. You, R., Zou, X., Ding, X., et al.[2022]

In a phase 2 trial involving 42 patients with unresectable locally advanced oesophageal squamous cell carcinoma, the combination of toripalimab with chemoradiotherapy resulted in a 62% complete response rate after 3 months, indicating promising efficacy for this treatment approach.

The treatment was generally well-tolerated, with a 1-year overall survival rate of 78.4% and a median duration of response of 12.1 months, although lymphopenia was a common adverse effect, affecting 86% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toripalimab combined with definitive chemoradiotherapy in locally advanced oesophageal squamous cell carcinoma (EC-CRT-001): a single-arm, phase 2 trial. Zhu, Y., Wen, J., Li, Q., et al.[2023]

In a phase 3 trial involving 263 patients with recurrent or metastatic nasopharyngeal carcinoma, the combination of camrelizumab with gemcitabine and cisplatin significantly improved progression-free survival compared to placebo, with a median of 9.7 months versus 6.9 months, indicating its potential as an effective first-line treatment.

While the treatment was associated with common adverse events like decreased white blood cell and neutrophil counts, serious adverse events occurred in 44% of patients receiving camrelizumab, suggesting a need for careful monitoring, especially since treatment-related deaths were reported in 4% of patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial. Yang, Y., Qu, S., Li, J., et al.[2022]

References

1. China pubmed.ncbi.nlm.nih.gov

Combined chemotherapy with cisplatin, docetaxel and capecitabine for metastatic nasopharyngeal carcinoma: a retrospective analysis. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Gemcitabine combined with apatinib and toripalimab in recurrent or metastatic nasopharyngeal carcinoma. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Toxicity of Three Induction Chemotherapy Regimens in Locoregionally Advanced Nasopharyngeal Carcinoma: Outcomes of 10-Year Follow-Up. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02). [2023]

6. England pubmed.ncbi.nlm.nih.gov

Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Comparative safety and efficacy of anti-PD-1 monotherapy, chemotherapy alone, and their combination therapy in advanced nasopharyngeal carcinoma: findings from recent advances in landmark trials. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Toripalimab combined with definitive chemoradiotherapy in locally advanced oesophageal squamous cell carcinoma (EC-CRT-001): a single-arm, phase 2 trial. [2023]

9. New Zealand pubmed.ncbi.nlm.nih.gov

A comparison of neoadjuvant chemotherapy with gemcitabine versus docetaxel plus cisplatin in locoregionally advanced nasopharyngeal carcinoma: a propensity score matching analysis. [2022]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Gemcitabine Combined with Cisplatin Has a Better Effect in the Treatment of Recurrent/Metastatic Advanced Nasopharyngeal Carcinoma. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial. [2022]