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A prospective, single-arm, exploratory study for Camrelizumab combined with TP chemotherapy for first-line treatment in patients with recurrent/metastatic or locally advanced inoperable oral squamous cell carcinoma

A prospective, single-arm, exploratory study for Camrelizumab combined with TP chemotherapy for first-line treatment in patients with recurrent/metastatic or locally advanced inoperable oral squamous cell carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026736
Enrollment
Unknown
Registered
2019-10-20
Start date
2019-12-01
Completion date
Unknown
Last updated
2019-10-21

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

Conditions

oral squamous cell carcinoma

Interventions

experimental group:Camrelizumab+TP

Sponsors

Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-75 years,Gender is not limited; 2. Oral squamous cell carcinoma; 3. Always do not accept any system antitumor drugs; 4. ECOG = 12 weeks; 6. Patients with adequate organ function at the time of enrollment as defined below: (1) Blood routine examination standard (without blood transfusion within 14 days before enrollment): Hb >=90g/L; WBC>=3.0x10^9/L; ANC >=1.5x10^9/L; PLT >=80x10^9/L; (2) Biochemical examination shall meet the following standards: BIL 50ml/min (Cockcroft-Gault math); 7. Women of childbearing age in the serum or urine pregnancy test is negative within 7 days prior to study enrollment and must be Non-lactating patients and agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 8 months after the end of the study males should agree to patients who must use contraception during the study period and within 12 months after the end of the study period; 8. Informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have received anti-tumor treatment in the past; 2. The patient has any active autoimmune disease or a history of autoimmune disease; 3. Patients who cannot complete the necessary treatment plan and follow-up observation; 4. Other situations in which investigators thought the patients not suit to be included.

Design outcomes

Primary

MeasureTime frame
Overall Survival;

Secondary

MeasureTime frame
progress free survival;side effecs;Duration of Response;

Countries

China

Contacts

Public ContactRen Guoxin

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

renguoxincn@sina.com+86 13916948812

Outcome results

None listed

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