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Monoclonal Antibodies

Gemcitabine + Docetaxel + Toripalimab for Nasopharyngeal Cancer

Phase 2

Recruiting

Led By A. Dimitrios Colevas, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age: At least 18 years old

Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-3. No M1) per AJCC v 8

Must not have

Concurrent use of any anti- cancer treatment, standard, alternative or investigational

Myocardial infarction within the last 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to determine if the new drug is safe and effective for people with cancer."

Who is the study for?

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.

What is being tested?

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

What are the potential side effects?

While specific side effects are not listed, common ones for drugs like Toripalimab may include immune-related reactions, fatigue, skin issues, nausea, and potential complications from chemotherapy and radiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old.

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My cancer is advanced but hasn't spread beyond the local region.

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My kidney function is normal or only slightly reduced.

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I agree to use effective birth control during and for 4 months after my treatment.

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I can care for myself and am up and about more than 50% of my waking hours.

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I have not received any treatment for nasopharyngeal cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently using any cancer treatments.

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

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I have received systemic anticancer treatment for nasopharyngeal cancer.

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I have had radiation therapy to my head or neck.

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I have not had unstable heart pain or uncontrolled heart failure in the last 6 months.

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I haven't been hospitalized for COPD or other lung issues in the last 30 days.

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I have moderate to severe numbness, tingling, or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Induction chemotherapy completion rate

Radiation completion rate

Secondary study objectives

Complete Response (CR) rate following radiation

Overall Response (ORD) rate following induction

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Gemcitabine, Docetaxel and CapecitabineExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Toripalimab

2017

Completed Phase 3

~1260

0 / 13Eligibility criteria met