Combining toripalimab with chemoradiotherapy for cervical cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness and safety of adding toripalimab, a PD-1 inhibitor, to concurrent platinum-based chemoradiotherapy in patients with locally advanced cervical cancer. The study aims to determine how this combination therapy impacts treatment outcomes compared to standard approaches. It is a single-arm, phase II trial that includes patients who have not received prior treatment for their condition. The trial will assess both the efficacy and tolerance of this combined treatment regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age between 18 and 75;
* Untreated patients with pathologically proven locally advanced cervical cancer;
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Adequate hematological, renal and hepatic functions:

  1. Hemoglobin \> 8.0 g/dl
  2. Neutrophils \> 2000 cells/μl; Leukocytes \> 4 × 109/L
  3. Platelets \> 100 × 109/L

  g. Serum urea nitrogen (BUN) ≤ 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) ≤ 1.5 × upper normal limit (UNL) d. Serum ALT/AST ≤ 2.5× UNL e. Serum Total bilirubin ≤ 1.5× UNL
* Life expectancy \> 6 months
* Eligible for concurrent chemoradiotherapy assessed by principle investigator;
* No obvious active bleeding;
* Written informed consent must be available before study registration

Exclusion Criteria:

* Recurrent or distant metastatic disease;
* Prior malignancies (other than curable non-melanoma skin cancer) within 5 years;
* Active autoimmune diseases requiring systemic treatment or other diseases requiring long-term use of substantial amount of hormones or other immunosuppressants;
* Patients who need to receive systemic corticosteroids (dose equivalent to or higher than prednisone 10mg qd) or other immunosuppressants within 14 days before enrollment or during the study;
* Vaccination of live attenuated vaccine 30 days before enrollment, or planned vaccination of live attenuated vaccine during the study;
* Previous organ transplantation or HIV patients;
* Allergic to macromolecular proteins /monoclonal antibodies, or to any test drug component;
* Active acute or chronic viral hepatitis B or C. Hepatitis B virus (HBV) DNA\> 2000IU/ml or 104 copies/ml; hepatitis C virus (HCV) RNA\> 103 copies/ml.

Where it's running

• Tianjin Medical University Cancer Institute&Hospital
  Tianjin, Tianjin, China Recruiting

Study contacts

• Study coordinator: Jie Chen
• Email: tjcjvip@126.com
• Phone: +86-18622221202

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Combining Toripalimab with Chemoradiotherapy for Cervical Cancer

  This study is testing if adding an immunotherapy drug called toripalimab to standard treatment can help women with newly diagnosed locally advanced cervical cancer do better than with just the standard treatment alone.

  Recruiting Ruijin Hospital · Shanghai, Shanghai Municipality · NCT06256224

• Cervical screening and care options for women living with HIV who test positive for high-risk HPV

  This study tests different ways to screen and manage high-risk HPV in women with HIV to see what might work best for them.

  Recruiting University of California, San Diego · Nairobi · NCT07925307

• Hydrogel spacer to protect the rectum during cervical cancer radiotherapy

  This study tests whether placing an absorbable hydrogel spacer between the cervix/vagina and rectum before definitive radiotherapy can reduce rectal radiation exposure for women with cervical cancer.

  Recruiting Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07904182

• How cinema sessions during chemotherapy might help cervical cancer patients

  We’re testing if watching films during chemotherapy helps cervical cancer patients feel less anxious and improve quality of life.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma · NCT07902180

• TMV vaccine alone or with toripalimab for recurrent head and neck cancer

  This study tests a personalized TMV vaccine, alone and with toripalimab, in adults whose head and neck cancer has returned and is planning salvage surgery.

  Recruiting Phase 1 Metaclipse Therapeutics Corporation · Houston, Texas · NCT07898124

• Toripalimab Plus Cetuximab and Irinotecan for second-line right-sided colon cancer

  This phase II study tests whether a combo of toripalimab, cetuximab, and irinotecan helps adults with second-line, right‑sided, RAS/BRAF wild-type advanced colon cancer.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07896681

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.