Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer Patients With High Risk of Recurrence: A Prospective, Single-Arm, Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06093438
• Other study ID #: 2020230207083952035
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 1, 2023
• Est. completion date: July 1, 2026

Study information

• Verified date: September 2023
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: Yuanjie Cao
• Phone: +86-18522123151
• Email: cyjro325[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To explore the efficacy of incorporating neoadjuvant immunotherapy into neoadjuvant chemotherapy in locally advanced cervical cancer patients with high risk of recurrence.

Description:

For locally advanced cervical cancer patients undergoing definitive chemoradiotherapy, distant metastasis has become a major concern. In this study, investigators selected a subgroup of patients with theoretically higher risk of distant metastasis and intensified their systematic treatment by incorporating PD-L1 inhibitors into neoadjuvant chemotherapy, in order to reduce their risk of distant metastasis and achieve good disease-free survival.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 1, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Untreated locally advanced cervical cancer patients with clear pathological diagnosis

2. 2019 FIGO stage IIIB-IVA. For patients with stage IIIC disease, the short diameter of their metastatic lymph nodes should =1.5cm

3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

4. Life expectancy > 6 months

5. Able to tolerate concurrent chemoradiotherapy assessed by researches

6. No obvious active bleeding;

7. Adequate hematological, renal and hepatic functions:

8. No concomitant malignancies

9. Female subjects of childbearing potential should have a negative pregnancy test and must take effective and reliable contraceptive measures during the clinical trial period;

10. Voluntarily-signed informed consent.

Exclusion Criteria:

1. Concomitant other malignancies;

2. Patients with metastatic or recurrent disease;

3. Patients received any form of treatment before enrollment;

4. Severe concomitant chronic diseases (diabetes, hypertension, etc.) or acute infections;

5. Impaired hematological, renal or hepatic functions:

1. Hemoglobin < 9.0 g/dl

2. Neutrophils < 2000 cells/µl; Leukocytes < 4 × 109/L

3. Platelets > 100 × 109/L

4. Serum ALT/AST > 2.5×UNL

5. Serum Total bilirubin > 1.5× UNL

g. Serum urea nitrogen (BUN) > 1.5 × upper normal limit (UNL) h. Serum creatinine (Cr) > 1.5 × upper normal limit (UNL)

6. Patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency or severe heart valve disease;

7. Patients with uncontrolled mental diseases;

8. Pregnant or lactating woman;

9. Participating in other clinical trials;

10. Anyone considered not suitable for enrollment by principal investigator;

Related Conditions & MeSH terms

• Cervical Cancer
• Immunotherapy
• Induction Chemotherapy
• Uterine Cervical Neoplasms

Intervention

Drug:
• Toripalimab
Patients enrolled in this arm would receive three cycles of induction treatment before receiving definitive chemoradiotherapy. The specific regimen is: Paclitaxel(135mg/m2,ivd, d1)+cisplatin(75mg/m2,ivd,d1-3)+Toripalimab (240mg,ivd,d1)±bevacizumab(ivd, d1)/q21d. Patients would receive pelvic MRI to evaluate the regression status of tumor after three cycles of induction treatment. Patients with satisfying tumor regression would receive definitive chemoradiotherapy afterwards. During chemoradiotherapy, patients would receive weekly cisplatin (40mg/m2) and 240mg toripalimab every three weeks. After chemoradiotherapy, patients would receive another three cycles of consolidated treatment (regimen identical to induction treatment).

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1	1 year
Primary	Volume changes of core radiation targets and irradiated normal tissues after induction treatment	Volume change of PTV, PGTVnd, Bladder V45, V50, Dmax, Dmean, Rectum V45, V50, Dmax, Dmean, Bowel bag V45, V50	5-year
Secondary	Progression-free survival	Time from diagnosis of disease to disease progression or death due to any cause	1-year, 2-year
Secondary	Distant metastasis-free survival	Time from diagnosis to distant metastasis or death due to any cause	1-year, 2-year
Secondary	Incidence of treatment-related side effects	Incidence of treatment-related side effects (i.e., radiation-related proctitis, cystitis, ,vaginitis, etc.)	5-year