Health TrialsbyHealthPanel

SHR-1701 Combined With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma With Peritoneal Metastasis

ConditionGastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital

About this trial

This study is a prospective, randomized, two-cohort trial designed to evaluate the efficacy and safety of two regimens in the treatment of gastric or gastroesophageal junction adenocarcinoma with peritoneal metastasis: SHR-1701 combined with intravenous and intraperitoneal paclitaxel plus S-1, or SHR-1701 combined with CAPOX.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old.

Pathologically confirmed gastric or gastroesophageal junction adenocarcinoma (Siewert typeⅡ and type Ⅲ gastroesophageal junction adenocarcinoma are eligible for inclusion).

Definitively diagnosed with peritoneal metastasis by exploratory laparoscopy and/peritoneal lavage cytology (CY0P1/CY1P0/CY1P1 are eligible, ovarian metastasis is permitted), and without gastric outlet obstruction or intestinal obstruction.

No prior anti-tumor treatment history (including radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc.).

Disqualifiers

Known HER2-positive.

Previous history of gastric cancer surgery.

Contraindications to surgical treatment or chemotherapy, or poor physical status and organ function precluding major abdominal surgery.

Presence of distant metastases other than peritoneal metastases (e.g., liver, lung, ovarian, para-aortic lymph node, brain metastases, etc.).

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-1701

    Drug

    SHR-1701, 1800mg, Q3w

  • Capecitabine

    Drug

    Capecitabine, Q3W

  • S-1

    Drug

    S-1, Q3W

  • Paclitaxel

    Drug

    Paclitaxel,Q3W

  • Oxaliplatin

    Drug

    Oxaliplatin, Q3W

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SHR-1701 and intravenous/intraperitoneal paclitaxel and S-1Experimental treatment 3 interventions
Group B: SHR-1701 and CAPOXExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

2-year overall survival rate

Time frame
Up to 2 years

Secondary outcomes

1

Conversion surgery rate

Time frame
Up to 4 weeks after completion of surgery
2

R0 resection rate

Time frame
Up to 4 weeks after completion of surgery
3

Pathological complete response(pCR)

Time frame
Up to 4 weeks after completion of surgery
4

Tumor regression grade

Time frame
Up to 4 weeks after completion of surgery

Other outcomes

Sponsors and contacts

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

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now