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Toripalimab Combined with Concurrent Chemoradiotherapy in Stage IV Hypopharyngeal Carcinoma without Distant Metastasis

Safety and efficacy of Toripalimab- a PD-1 inhibitor- combined with concurrent chemotherapy in patients with stage IV hypopharyngeal carcinoma without distant metastasis: a randomize, multicenter, open label, phase II trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043981
Enrollment
Unknown
Registered
2021-03-06
Start date
2019-07-01
Completion date
Unknown
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypopharyngeal cancer

Interventions

experimental group:Toripalimab combined with concurrent chemotherapy
control group:concurrent chemotherapy

Sponsors

National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Refuse surgery or can't be operated after multidisciplinary team discussion; 2. Pathology confirmed squamous cell carcinoma; 3. Aged 18-70 years old; 4. Stage IVa/b diseases according to 8th AJCC Staging; Treatment for the first time; 5. ECOG scores <=1; 6. Without contraindication of chemotherapy, radiotherapy and immunotherapy; Adequate main organs function, including blood routine examination, liver and kidney function, coagulation and myocardial enzyme are normal; 7. Need contraception during reproductive age; 8. Can understand and sign the consent.

Exclusion criteria

Exclusion criteria: 1. Prior invasive malignancy (except cured basal cell carcinoma, carcinoma in situ of cervix, superficial bladder cancer); 2. Severe comorbidities including cardiovascular, cerebral vascular, mental disease; 3. Active infection; congenital and acquired immunodeficiency; 4. allergic to DDP or anti-PD-1 antibody; 5. women during pregnancy and lactation; 6. any other causes forcing to stop the tail, including sever toxicities, refuse following treatment schedule.

Design outcomes

Primary

MeasureTime frame
Effect and safety;

Countries

China

Contacts

Public ContactJunlin Yi

National Cancer Center /National Clinical Research Center for Cancer/Cancer Hospital, CAMS & PUMC

yijunlin1969@163.com+86 13661217998

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026