Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer

• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06093438
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer; Induction Chemotherapy; Immunotherapy	Drug: Toripalimab	Phase 1/Phase 2

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Induction Toripalimab and Chemotherapy in Locally Advanced Cervical Cancer Patients With High Risk of Recurrence: A Prospective, Single-Arm, Phase II Trial
• Actual Study Start Date: Jul 1, 2023
• Anticipated Primary Completion Date: Jul 1, 2025
• Anticipated Study Completion Date: Jul 1, 2026

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Induction immunotherapy and chemotherapy Patients enrolled in this arm would receive neoadjuvant immunotherapy and chemotherapy before definitive chemoradiation

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).

Outcome Measures

Primary Outcome Measures

1. Overall response rate [1 year]

   The proportion of patients with at least one tumor scan of complete response (CR) or partial response (PR) using RECIST v1.1

2. Volume changes of core radiation targets and irradiated normal tissues after induction treatment [5-year]

   Volume change of PTV, PGTVnd, Bladder V45, V50, Dmax, Dmean, Rectum V45, V50, Dmax, Dmean, Bowel bag V45, V50

Secondary Outcome Measures

1. Progression-free survival [1-year, 2-year]

   Time from diagnosis of disease to disease progression or death due to any cause

2. Distant metastasis-free survival [1-year, 2-year]

   Time from diagnosis to distant metastasis or death due to any cause

3. Incidence of treatment-related side effects [5-year]

   Incidence of treatment-related side effects (i.e., radiation-related proctitis, cystitis, ,vaginitis, etc.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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:

6. Hemoglobin < 9.0 g/dl

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

8. Platelets > 100 × 109/L

9. Serum ALT/AST > 2.5×UNL

10. Serum Total bilirubin > 1.5× UNL

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

1.5 × upper normal limit (UNL)

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

2. Patients with uncontrolled mental diseases;

3. Pregnant or lactating woman;

4. Participating in other clinical trials;

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin	China	300060

Sponsors and Collaborators

• Tianjin Medical University Cancer Institute and Hospital

Investigators

• Principal Investigator: Jie Chen, Tianjin Medical University Cancer Institute & Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tianjin Medical University Cancer Institute and Hospital
• ClinicalTrials.gov Identifier: NCT06093438
• Other Study ID Numbers: 2020230207083952035
• First Posted: Oct 23, 2023
• Last Update Posted: Oct 23, 2023
• Last Verified: Sep 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tianjin Medical University Cancer Institute and Hospital: cervical cancer; immunotherapy; neoadjuvant chemotherapy; chemoradiation
• Additional relevant MeSH terms: Uterine Cervical Neoplasms

Study Results

No Results Posted as of Oct 23, 2023