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Concurrent Chemoradiotherapy Followed by PD-1 Inhibitor in Advanced Cervical Cancer

ConditionsLocally Advanced Cervical CarcinomaConcurrent ChemoradiotherapyImmunotherapy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorRenJi Hospital

About this trial

To explore the safety and efficacy of Albumin-Bound Paclitaxel/Platinum based concurrent chemoradiotherapy Followed by PD-1 inhibitor (Sintilimab) in locally advanced cervical cancer

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 75;

Untreated patients with pathologically proven locally advanced cervical cancer;

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

Life expectancy > 6 months

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • Albumin-Bound Paclitaxel, cisplatin, Sintilimab

    Drug

    with Albumin-Bound Paclitaxel 50-75mg/m2, cisplatin 25-40 mg/m2 weekly for up to 5 cycles during radical radiation; followed by Sintilimab 200mg Q3W for 8 cycles

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: treatment armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

progression disease free survival

the time interval from the date of treatment to disease progression, local or distant recurrence.

Time frame
-2 years
2

safety of Albumin-Bound Paclitaxel/cisplatin based concurrent chemoradiotherapy followed by Sintilimab

the occurrence and grade of side effect from treatment according to the CTCAE 4.0 and NCCN clinical practice guidelines in the evaluation treatment-related toxicity (through the symptoms, physical examination, and also through blood/image/encoscopy examination, such as blood routine, liver and renal function, TSH/T3/T4/ACTH concentration, myocardial enzymes, and EKG, echocardiography, CT, et al).

Time frame
-1 years

Secondary outcomes

1

Objective Response Rate (ORR)

the percentage of the participants in the population who have a Complete Response or Partial Response accordingly to RECIST 1.1

Time frame
3 months
2

distant-metastasis free survival

the time interval from the date of treatment to distant recurrence.

Time frame
-2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov
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