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Clinical Trial
. 2022 Nov 10;13(1):6807.
doi: 10.1038/s41467-022-34403-5.

The Neo-PLANET phase II trial of neoadjuvant camrelizumab plus concurrent chemoradiotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction

Zhaoqing Tang #  1   2 , Yan Wang #  3 , Dan Liu #  1 , Xuefei Wang #  4   5 , Chen Xu  6 , Yiyi Yu  3 , Yuehong Cui  3 , Cheng Tang  3 , Qian Li  3 , Jing Sun  7 , Qian Zhang  7 , Yuan Ji  6 , Guifen Ma  7 , Haojie Li  1 , Zhenbin Shen  1 , Kuntang Shen  1 , Rongrong Zheng  8 , Zhiguo Hou  8 , Tianshu Liu  9   10 , Jiping Wang  11 , Yihong Sun  12   13
Affiliations
Clinical Trial

The Neo-PLANET phase II trial of neoadjuvant camrelizumab plus concurrent chemoradiotherapy in locally advanced adenocarcinoma of stomach or gastroesophageal junction

Zhaoqing Tang et al. Nat Commun. .

Abstract

The synergistic effect of neoadjuvant immunotherapy and chemoradiotherapy in gastric adenocarcinoma is unclear. This phase II trial (NCT03631615) investigated this neoadjuvant combination in locally advanced adenocarcinoma of stomach or gastroesophageal junction. Thirty-six patients received capecitabine 850 mg/m2 twice daily and simultaneous radiotherapy for 5 weeks, sandwiched by a 21-day cycle of oxaliplatin 130 mg/m2 (day 1) plus capecitabine 1000 mg/m2 twice daily (days 1-14), respectively, followed by surgery. Camrelizumab 200 mg (day 1) was given for 5 cycles since initiating chemotherapy. Primary endpoint was pathological complete response (pCR, ypT0) rate. Secondary endpoints included total pCR (tpCR, ypT0N0) rate, major pathological response (MPR, < 10% residual tumor cells) rate, margin-free (R0) resection rate, downstaging, progression-free survival (PFS), overall survival (OS), and safety. The pCR rate was 33.3% (95% CI, 18.6-51.0), meeting pre-specified endpoint. TpCR, MPR, and R0 resection rates were 33.3%, 44.4%, and 91.7%, respectively. Twenty-eight (77.8%) patients reached ypN0. Two-year PFS and OS rates were 66.9% and 76.1%, respectively. The most common grade 3-4 adverse event was decreased lymphocyte count (27 [75.0%]). Neoadjuvant camrelizumab plus concurrent chemoradiotherapy exhibits promising pathological response in patients with locally advanced gastric adenocarcinoma, with an acceptable safety profile.

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Conflict of interest statement

Rongrong Zheng and Zhiguo Hou are employees of Jiangsu Hengrui Pharmaceuticals Co., Ltd. The remaining authors declare no competing interests.

Figures

Fig. 1
Fig. 1. Study design and Consort diagram.
a Trial schema and sample collection. b Consort diagram. XELOX, capecitabine and oxaliplatin, WES whole-exome sequencing.
Fig. 2
Fig. 2. Tumor response to neoadjuvant therapy.
a Waterfall plot of tumor regression by pathology (n = 33). b Representative radiological and pathological images (HE staining, ×40, ×200) from responsive (NP025) and nonresponsive (NP018) patients. HE staining was performed one time in 33 independent samples with similar results. c Representative pathological features (HE staining, ×200) after immunotherapy. HE staining was performed one time in 33 independent samples with similar results. CPS combined positive score, UTA unable to access, GEJ gastroesophageal junction, MPR major pathologic response, HE hematoxylin and eosin, TLS tertiary lymphoid structures, TILs tumor-infiltrating lymphocytes. Source data are provided as a Source Data file.
Fig. 3
Fig. 3. Follow-up and survival.
a Swimming plot showing events during treatment and follow-up (n = 36). b Kaplan–Meier curves for overall survival in the full analysis set. c Kaplan–Meier curves for overall survival in patients with or without pCR. A two-sided log-rank test was used to determine the statistical significance between subgroups. d Kaplan–Meier curves for overall survival in patients with or without MPR. A two-sided log-rank test was used to determine the statistical significance between subgroups. e Kaplan–Meier curves for progression-free survival in the full analysis set. f Kaplan–Meier curves for progression-free survival in patients with or without pCR. A two-sided log-rank test was used to determine the statistical significance between subgroups. g Kaplan–Meier curves for progression-free survival in patients with or without MPR. A two-sided log-rank test was used to determine the statistical significance between subgroups. pCR pathological complete response, MPR major pathological response. Source data are provided as a Source Data file.
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