The efficacy and safety of toripalimab (JS001) with concurrent chemoradiotherapy in locally advanced cervical cancer, a prospective, single arm, single center clinical study

The efficacy and safety of toripalimab (JS001) with concurrent chemoradiotherapy in locally advanced squamous cell cervical cancer, a prospective, single arm, single center clinical study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000032879

Enrollment

Unknown

Registered

2020-05-14

Start date

2020-06-01

Completion date

Unknown

Last updated

2020-05-18

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

Conditions

Cervical cancer

Interventions

Case series:concurrent chemoradiotherapy with toripalimab

Eligibility

Sex/Gender

Female

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with cervical squamous cell carcinoma confirmed by histopathology; 2. FIGO stage (2018): stage I b3-IVA; or any condition that cannot receive surgery and requires radical radiotherapy; 3. Patients with expected survival >=6 months; 4. Patients aged 18 to 70 years old; 5. Patients with ECoG 0-1; 6. Patients with sufficient main organ function (1) Hemopoietic function: hemoglobin >=100g/L, platelet >=90x10^9/L, neutrophil >=1.5x10^9/L; (2) Renal function: serum creatinine SCR<1.5 ULN; (3) Liver function: ALT and AST < ULN one point five Times, bilirubin <1.5 ×ULN; 7. The patient must sign the informed consent of receiving trepril monoclonal antibody (PD-1 monoclonal antibody) combined with concurrent radiotherapy and chemotherapy.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously suffered from or complicated with other malignant tumors (except melanoma skin tumors) and whose diseases are not controlled or cured (depending on the disease type of the primary tumor); 2. Patients who have previously received abdominal or pelvic radiotherapy; 3. Patients who have received immunotherapy before, including tumor vaccine, cytokines, anti-CTLA-4, anti-PD-1, and anti-PD-L1, etc; 4. Patients with congenital or acquired immune deficiency; 5. HIV positive patients, including those who have received antiretroviral therapy; chronic hepatitis B, virus replication period; active period of hepatitis C; 6. Pregnancy (confirmed by serum or urine beta- hCG test) or lactation period; 7. The general condition of the patients was poor, KPS 2; 8. Patients have conditions that researchers believe may increase the risk of treatment or have serious uncontrollable complications.

Design outcomes

Primary

Measure	Time frame
dose-limiting toxicity, DLT;2-year progression-free survival;	—

Secondary

Measure	Time frame
2 year-local control;2-year local-regional control;2 year-overall survival;	—

Countries

China

Contacts

Public ContactXu Haoping

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

xhp11701@rjh.com.cn+86 13818432682

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026