Optimizing Neoadjuvant Treatment Regimens for Locally Advanced Esophageal Squamous Cell Carcinoma

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital

About this trial

Our previous study, a single-center, prospective, single-arm Phase II study (Keypoint001) has demonstrated the efficacy and safety of neoadjuvant chemotherapy combined with immunotherapy in locally advanced (cT3-4N+M0) esophageal squamous cell carcinoma. The results show that the pathological complete response rate (pCR) reaches 35%, and the major pathological response rate is over 70%, which is much higher than that of patients receiving chemotherapy alone. Meanwhile, no severe adverse drug reactions have been found in terms of safety, so this treatment regimen is safe and reliable.

However, the cycle of neoadjuvant immunotherapy is still under exploration. Currently, the mainstream research centers adopt a regimen of 2 to 4 cycles. The exploration results of our center have found that most patients' conditions can be further alleviated after 4 cycles compared with after 2 cycles, but there are still a small number of patients with no obvious remission. Therefore, we consider observing whether patients with no obvious remission can achieve a better pathological response rate through further radiotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

male or female

Age ≥ 18 years old

Pathological confirmation of esophageal squamous cell carcinoma

Endoscopic ultrasound, enhanced CT scan of the neck, chest, and abdomen, and esophageal magnetic resonance imaging evaluate as T3 or resectable T4 PET/CT、 Cervical, thoracic, and abdominal enhanced CT evaluation of N0 or N+

Disqualifiers

T staging evaluation is T1/T2

PET/CT and other evaluations show distant metastasis (M1)

Planned pregnancy or patients during pregnancy or lactation

History of previous chemotherapy, radiation therapy, or immunotherapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Chemotherapy

    Drug

    carboplatin plus nab-paclitaxel

  • Immunotherapy (Pembrolizumab)

    Drug

    Pembrolizumab

  • radiotherapy

    Radiation

    40-45Gy/20fx,5 times a week

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: 2 cycles chemoimmunotherapy plus surgeryExperimental treatment 2 interventions
Group B: 4 cycles chemoimmunotherapy plus surgeryExperimental treatment 2 interventions
Group C: 4 cycles chemoimmunotherapy plus radiotherapy and surgeryExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pathological response

Postoperative pathology according to CAP classification.

Time frame
After surgery
2

2-year and 5-year overall survival

overall survival after 2 years and 5 years

Time frame
2 years and 5 years after therapy

Secondary outcomes

1

Adverse effect incidence

Adverse effect according to CTCAE and RTOG criteria

Time frame
1 years after therapy
2

R0 resection rate

Time frame
After surgery
3

postoperative complications

postoperative complications according to Clavien-Dindo classification

Time frame
After surgery
4

2-year and 5-year disease-free survival

disease-free survival after 2 years and 5 years

Time frame
2 years and 5 years after therapy

Other outcomes

Sponsors and contacts

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

Peking Union Medical College Hospital

Lead sponsor

Military 301 Hospital

Collaborator

Peking University Cancer Hospital & Institute

Collaborator

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Collaborator